Reported covered position: N/A
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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Financial CHOICE Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Market Enhancements ---Accredited Investor Definition ---Fair Investment Opportunities for Professional Experts Act (House Discussion Draft) ---H.R. 1312/S.416: Small Business Capital Formation Enhancement Act ---H.R. 1343/S.488: Encouraging Employee Ownership Act ---SEC Rule 701 ---SEC Small Business Forum Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---H.R. 10: Financial CHOICE Act Proxy Advisory Services ---Corporate Governance Reform and Transparency Act (House Discussion Draft) ---H.R. 10: Financial CHOICE Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Accredited Investor Certification ---H.R. 10: Financial CHOICE Act ---H.R. 79/S. 588: HALOS Act Sarbanes Oxley Section 404 (b) ---H.R. 10: Financial CHOICE Act ---H.R. 1645: Fostering Innovation Act ---Small Issuer Exemption Short Selling Transparency XBRL Exemption for Small Public Companies ---H.R. 10: Financial CHOICE Act ---Small Company Disclosure Simplification Act (House Discussion Draft)
RACE for Children Act
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2017 · second_quarter · Q2
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---The Better Care Reconciliation Act of 2017 (Senate Discussion Drafts) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of Medical Countermeasures Innovation Act ---Tropical Disease Priority Review Voucher (PRV) Program ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Patent Certification ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Proposed Rule on Changes to Drug Labeling ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Reauthorization of the Prescription Drug User Fee Act ---Special Medical Use/Limited Population Drug ---Use of Real-World Evidence ---S.204 -H.R. 878: Rights to Try Act of 2017 ---S.456 - H.R. 1231: RACE for Children Act ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---Welch Amendment to: H.R. 2430: FDA Reauthorization Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Product Communications ---The Medical Products Communications Act of 2017 (Rep. Griffith Discussion Draft) ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Funding for Antimicrobial Resistance Programs ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Department of Defense Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Orphan Drug Issues ---RACE for Children Act (Discussion Draft) ---Tax Credit ---Technical Amendments ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---H.R. 1628: American Health Care Act ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Foreign Drug Data Protection Laws ---Israel Trade and Foreign Drug Price Controls
Source: Senate LDA
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---The Better Care Reconciliation Act of 2017 (Senate Discussion Drafts) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of Medical Countermeasures Innovation Act ---Tropical Disease Priority Review Voucher (PRV) Program ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Patent Certification ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Proposed Rule on Changes to Drug Labeling ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Reauthorization of the Prescription Drug User Fee Act ---Special Medical Use/Limited Population Drug ---Use of Real-World Evidence ---S.204 -H.R. 878: Rights to Try Act of 2017 ---S.456 - H.R. 1231: RACE for Children Act ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---Welch Amendment to: H.R. 2430: FDA Reauthorization Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Product Communications ---The Medical Products Communications Act of 2017 (Rep. Griffith Discussion Draft) ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Funding for Antimicrobial Resistance Programs ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Department of Defense Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Orphan Drug Issues ---RACE for Children Act (Discussion Draft) ---Tax Credit ---Technical Amendments ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---H.R. 1628: American Health Care Act ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Foreign Drug Data Protection Laws ---Israel Trade and Foreign Drug Price Controls
Small Business Capital Formation Enhancement Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Market Enhancements ---Accredited Investor Definition ---Fair Investment Opportunities for Professional Experts Act (House Discussion Draft) ---H.R. 1312/S.416: Small Business Capital Formation Enhancement Act ---H.R. 1343/S.488: Encouraging Employee Ownership Act ---SEC Rule 701 ---SEC Small Business Forum Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---H.R. 10: Financial CHOICE Act Proxy Advisory Services ---Corporate Governance Reform and Transparency Act (House Discussion Draft) ---H.R. 10: Financial CHOICE Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Accredited Investor Certification ---H.R. 10: Financial CHOICE Act ---H.R. 79/S. 588: HALOS Act Sarbanes Oxley Section 404 (b) ---H.R. 10: Financial CHOICE Act ---H.R. 1645: Fostering Innovation Act ---Small Issuer Exemption Short Selling Transparency XBRL Exemption for Small Public Companies ---H.R. 10: Financial CHOICE Act ---Small Company Disclosure Simplification Act (House Discussion Draft)
Small Business Capital Formation Enhancement Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Market Enhancements ---Accredited Investor definition ---SEC Small Business Forum ---SEC Rule 701 ---PCAOB Audit Cost Increases ---Fair Investment Opportunities for Professional Experts Act (House Discussion Draft) ---H.R. 1343/S.488: Encouraging Employee Ownership Act ---H.R. 1312/S.416: Small Business Capital Formation Enhancement Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) Proxy Advisory Services ---Impact of Policies on Small Public Companies ---Corporate Governance Reform and Transparency Act (House Discussion Draft) ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---Accredited Investor Certification ---Financial CHOICE Act (House Discussion Draft) ---H.R. 79/S. 588: HALOS Act Sarbanes Oxley Section 404 (b) ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1645: Fostering Innovation Act Short Selling Transparency Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---Small Company Disclosure Simplification Act (House Discussion Draft)
Encouraging Employee Ownership Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Market Enhancements ---Accredited Investor Definition ---Fair Investment Opportunities for Professional Experts Act (House Discussion Draft) ---H.R. 1312/S.416: Small Business Capital Formation Enhancement Act ---H.R. 1343/S.488: Encouraging Employee Ownership Act ---SEC Rule 701 ---SEC Small Business Forum Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---H.R. 10: Financial CHOICE Act Proxy Advisory Services ---Corporate Governance Reform and Transparency Act (House Discussion Draft) ---H.R. 10: Financial CHOICE Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Accredited Investor Certification ---H.R. 10: Financial CHOICE Act ---H.R. 79/S. 588: HALOS Act Sarbanes Oxley Section 404 (b) ---H.R. 10: Financial CHOICE Act ---H.R. 1645: Fostering Innovation Act ---Small Issuer Exemption Short Selling Transparency XBRL Exemption for Small Public Companies ---H.R. 10: Financial CHOICE Act ---Small Company Disclosure Simplification Act (House Discussion Draft)
Encouraging Employee Ownership Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Market Enhancements ---Accredited Investor definition ---SEC Small Business Forum ---SEC Rule 701 ---PCAOB Audit Cost Increases ---Fair Investment Opportunities for Professional Experts Act (House Discussion Draft) ---H.R. 1343/S.488: Encouraging Employee Ownership Act ---H.R. 1312/S.416: Small Business Capital Formation Enhancement Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) Proxy Advisory Services ---Impact of Policies on Small Public Companies ---Corporate Governance Reform and Transparency Act (House Discussion Draft) ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---Accredited Investor Certification ---Financial CHOICE Act (House Discussion Draft) ---H.R. 79/S. 588: HALOS Act Sarbanes Oxley Section 404 (b) ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1645: Fostering Innovation Act Short Selling Transparency Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---Small Company Disclosure Simplification Act (House Discussion Draft)
American Health Care Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases
American Health Care Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---The Better Care Reconciliation Act of 2017 (Senate Discussion Drafts) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of Medical Countermeasures Innovation Act ---Tropical Disease Priority Review Voucher (PRV) Program ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Patent Certification ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Proposed Rule on Changes to Drug Labeling ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Reauthorization of the Prescription Drug User Fee Act ---Special Medical Use/Limited Population Drug ---Use of Real-World Evidence ---S.204 -H.R. 878: Rights to Try Act of 2017 ---S.456 - H.R. 1231: RACE for Children Act ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---Welch Amendment to: H.R. 2430: FDA Reauthorization Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Product Communications ---The Medical Products Communications Act of 2017 (Rep. Griffith Discussion Draft) ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Funding for Antimicrobial Resistance Programs ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Department of Defense Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Orphan Drug Issues ---RACE for Children Act (Discussion Draft) ---Tax Credit ---Technical Amendments ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---H.R. 1628: American Health Care Act ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Foreign Drug Data Protection Laws ---Israel Trade and Foreign Drug Price Controls
Fostering Innovation Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Market Enhancements ---Accredited Investor definition ---SEC Small Business Forum ---SEC Rule 701 ---PCAOB Audit Cost Increases ---Fair Investment Opportunities for Professional Experts Act (House Discussion Draft) ---H.R. 1343/S.488: Encouraging Employee Ownership Act ---H.R. 1312/S.416: Small Business Capital Formation Enhancement Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) Proxy Advisory Services ---Impact of Policies on Small Public Companies ---Corporate Governance Reform and Transparency Act (House Discussion Draft) ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---Accredited Investor Certification ---Financial CHOICE Act (House Discussion Draft) ---H.R. 79/S. 588: HALOS Act Sarbanes Oxley Section 404 (b) ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1645: Fostering Innovation Act Short Selling Transparency Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---Small Company Disclosure Simplification Act (House Discussion Draft)
Fostering Innovation Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Market Enhancements ---Accredited Investor Definition ---Fair Investment Opportunities for Professional Experts Act (House Discussion Draft) ---H.R. 1312/S.416: Small Business Capital Formation Enhancement Act ---H.R. 1343/S.488: Encouraging Employee Ownership Act ---SEC Rule 701 ---SEC Small Business Forum Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---H.R. 10: Financial CHOICE Act Proxy Advisory Services ---Corporate Governance Reform and Transparency Act (House Discussion Draft) ---H.R. 10: Financial CHOICE Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Accredited Investor Certification ---H.R. 10: Financial CHOICE Act ---H.R. 79/S. 588: HALOS Act Sarbanes Oxley Section 404 (b) ---H.R. 10: Financial CHOICE Act ---H.R. 1645: Fostering Innovation Act ---Small Issuer Exemption Short Selling Transparency XBRL Exemption for Small Public Companies ---H.R. 10: Financial CHOICE Act ---Small Company Disclosure Simplification Act (House Discussion Draft)
Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---The Better Care Reconciliation Act of 2017 (Senate Discussion Drafts) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of Medical Countermeasures Innovation Act ---Tropical Disease Priority Review Voucher (PRV) Program ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Patent Certification ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Proposed Rule on Changes to Drug Labeling ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Reauthorization of the Prescription Drug User Fee Act ---Special Medical Use/Limited Population Drug ---Use of Real-World Evidence ---S.204 -H.R. 878: Rights to Try Act of 2017 ---S.456 - H.R. 1231: RACE for Children Act ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---Welch Amendment to: H.R. 2430: FDA Reauthorization Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Product Communications ---The Medical Products Communications Act of 2017 (Rep. Griffith Discussion Draft) ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Funding for Antimicrobial Resistance Programs ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Department of Defense Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Orphan Drug Issues ---RACE for Children Act (Discussion Draft) ---Tax Credit ---Technical Amendments ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---H.R. 1628: American Health Care Act ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Foreign Drug Data Protection Laws ---Israel Trade and Foreign Drug Price Controls
Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension Capital Formation Investment Incentives ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---An Act to Modify Net Operating Loss Carryforwards (House Discussion Draft) Orphan Drug Act Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---New Production Tax Credit
Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension Capital Formation Investment Incentives ---An Act to Modify Net Operating Loss Carryforwards (House Discussion Draft) ---H.R. 2297: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules Orphan Drug Issues ---Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit ---Production Tax Credit ---Expansion of Master Limited Partnerships to Renewable Chemicals ---HR 3149: Renewable Chemicals Act of 2017 Research & Development Tax Credit Reforms ---Refundable R&D Credit Treatment of Financial Interests as Stock or Indebtedness ---Section 385 Proposed Regulations Corporate Tax Reform
Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases
CREATES Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---The Better Care Reconciliation Act of 2017 (Senate Discussion Drafts) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of Medical Countermeasures Innovation Act ---Tropical Disease Priority Review Voucher (PRV) Program ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Patent Certification ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Proposed Rule on Changes to Drug Labeling ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Reauthorization of the Prescription Drug User Fee Act ---Special Medical Use/Limited Population Drug ---Use of Real-World Evidence ---S.204 -H.R. 878: Rights to Try Act of 2017 ---S.456 - H.R. 1231: RACE for Children Act ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---Welch Amendment to: H.R. 2430: FDA Reauthorization Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Product Communications ---The Medical Products Communications Act of 2017 (Rep. Griffith Discussion Draft) ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Funding for Antimicrobial Resistance Programs ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Department of Defense Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Orphan Drug Issues ---RACE for Children Act (Discussion Draft) ---Tax Credit ---Technical Amendments ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---H.R. 1628: American Health Care Act ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Foreign Drug Data Protection Laws ---Israel Trade and Foreign Drug Price Controls
PARTNER Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension Capital Formation Investment Incentives ---An Act to Modify Net Operating Loss Carryforwards (House Discussion Draft) ---H.R. 2297: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules Orphan Drug Issues ---Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit ---Production Tax Credit ---Expansion of Master Limited Partnerships to Renewable Chemicals ---HR 3149: Renewable Chemicals Act of 2017 Research & Development Tax Credit Reforms ---Refundable R&D Credit Treatment of Financial Interests as Stock or Indebtedness ---Section 385 Proposed Regulations Corporate Tax Reform
FDA Reauthorization Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---The Better Care Reconciliation Act of 2017 (Senate Discussion Drafts) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of Medical Countermeasures Innovation Act ---Tropical Disease Priority Review Voucher (PRV) Program ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Patent Certification ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Proposed Rule on Changes to Drug Labeling ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Reauthorization of the Prescription Drug User Fee Act ---Special Medical Use/Limited Population Drug ---Use of Real-World Evidence ---S.204 -H.R. 878: Rights to Try Act of 2017 ---S.456 - H.R. 1231: RACE for Children Act ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---Welch Amendment to: H.R. 2430: FDA Reauthorization Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Product Communications ---The Medical Products Communications Act of 2017 (Rep. Griffith Discussion Draft) ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Funding for Antimicrobial Resistance Programs ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Department of Defense Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Orphan Drug Issues ---RACE for Children Act (Discussion Draft) ---Tax Credit ---Technical Amendments ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---H.R. 1628: American Health Care Act ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Foreign Drug Data Protection Laws ---Israel Trade and Foreign Drug Price Controls
Review Every Dollar Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---The Better Care Reconciliation Act of 2017 (Senate Discussion Drafts) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of Medical Countermeasures Innovation Act ---Tropical Disease Priority Review Voucher (PRV) Program ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Patent Certification ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Proposed Rule on Changes to Drug Labeling ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Reauthorization of the Prescription Drug User Fee Act ---Special Medical Use/Limited Population Drug ---Use of Real-World Evidence ---S.204 -H.R. 878: Rights to Try Act of 2017 ---S.456 - H.R. 1231: RACE for Children Act ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---Welch Amendment to: H.R. 2430: FDA Reauthorization Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Product Communications ---The Medical Products Communications Act of 2017 (Rep. Griffith Discussion Draft) ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Funding for Antimicrobial Resistance Programs ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Department of Defense Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Orphan Drug Issues ---RACE for Children Act (Discussion Draft) ---Tax Credit ---Technical Amendments ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---H.R. 1628: American Health Care Act ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Foreign Drug Data Protection Laws ---Israel Trade and Foreign Drug Price Controls
Renewable Chemicals Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension Capital Formation Investment Incentives ---An Act to Modify Net Operating Loss Carryforwards (House Discussion Draft) ---H.R. 2297: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules Orphan Drug Issues ---Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit ---Production Tax Credit ---Expansion of Master Limited Partnerships to Renewable Chemicals ---HR 3149: Renewable Chemicals Act of 2017 Research & Development Tax Credit Reforms ---Refundable R&D Credit Treatment of Financial Interests as Stock or Indebtedness ---Section 385 Proposed Regulations Corporate Tax Reform
Lower Drug Costs through Competition Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases
Lower Drug Costs through Competition Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---The Better Care Reconciliation Act of 2017 (Senate Discussion Drafts) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of Medical Countermeasures Innovation Act ---Tropical Disease Priority Review Voucher (PRV) Program ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Patent Certification ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Proposed Rule on Changes to Drug Labeling ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Reauthorization of the Prescription Drug User Fee Act ---Special Medical Use/Limited Population Drug ---Use of Real-World Evidence ---S.204 -H.R. 878: Rights to Try Act of 2017 ---S.456 - H.R. 1231: RACE for Children Act ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---Welch Amendment to: H.R. 2430: FDA Reauthorization Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Product Communications ---The Medical Products Communications Act of 2017 (Rep. Griffith Discussion Draft) ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Funding for Antimicrobial Resistance Programs ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Department of Defense Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Orphan Drug Issues ---RACE for Children Act (Discussion Draft) ---Tax Credit ---Technical Amendments ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---H.R. 1628: American Health Care Act ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Foreign Drug Data Protection Laws ---Israel Trade and Foreign Drug Price Controls
HALOS Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Market Enhancements ---Accredited Investor definition ---SEC Small Business Forum ---SEC Rule 701 ---PCAOB Audit Cost Increases ---Fair Investment Opportunities for Professional Experts Act (House Discussion Draft) ---H.R. 1343/S.488: Encouraging Employee Ownership Act ---H.R. 1312/S.416: Small Business Capital Formation Enhancement Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) Proxy Advisory Services ---Impact of Policies on Small Public Companies ---Corporate Governance Reform and Transparency Act (House Discussion Draft) ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---Accredited Investor Certification ---Financial CHOICE Act (House Discussion Draft) ---H.R. 79/S. 588: HALOS Act Sarbanes Oxley Section 404 (b) ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1645: Fostering Innovation Act Short Selling Transparency Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---Small Company Disclosure Simplification Act (House Discussion Draft)
HALOS Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Market Enhancements ---Accredited Investor Definition ---Fair Investment Opportunities for Professional Experts Act (House Discussion Draft) ---H.R. 1312/S.416: Small Business Capital Formation Enhancement Act ---H.R. 1343/S.488: Encouraging Employee Ownership Act ---SEC Rule 701 ---SEC Small Business Forum Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---H.R. 10: Financial CHOICE Act Proxy Advisory Services ---Corporate Governance Reform and Transparency Act (House Discussion Draft) ---H.R. 10: Financial CHOICE Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Accredited Investor Certification ---H.R. 10: Financial CHOICE Act ---H.R. 79/S. 588: HALOS Act Sarbanes Oxley Section 404 (b) ---H.R. 10: Financial CHOICE Act ---H.R. 1645: Fostering Innovation Act ---Small Issuer Exemption Short Selling Transparency XBRL Exemption for Small Public Companies ---H.R. 10: Financial CHOICE Act ---Small Company Disclosure Simplification Act (House Discussion Draft)
Right to Try Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---The Better Care Reconciliation Act of 2017 (Senate Discussion Drafts) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of Medical Countermeasures Innovation Act ---Tropical Disease Priority Review Voucher (PRV) Program ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Patent Certification ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Proposed Rule on Changes to Drug Labeling ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Reauthorization of the Prescription Drug User Fee Act ---Special Medical Use/Limited Population Drug ---Use of Real-World Evidence ---S.204 -H.R. 878: Rights to Try Act of 2017 ---S.456 - H.R. 1231: RACE for Children Act ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---Welch Amendment to: H.R. 2430: FDA Reauthorization Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Product Communications ---The Medical Products Communications Act of 2017 (Rep. Griffith Discussion Draft) ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Funding for Antimicrobial Resistance Programs ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Department of Defense Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Orphan Drug Issues ---RACE for Children Act (Discussion Draft) ---Tax Credit ---Technical Amendments ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---H.R. 1628: American Health Care Act ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Foreign Drug Data Protection Laws ---Israel Trade and Foreign Drug Price Controls
Right to Try Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases
Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---The Better Care Reconciliation Act of 2017 (Senate Discussion Drafts) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of Medical Countermeasures Innovation Act ---Tropical Disease Priority Review Voucher (PRV) Program ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Patent Certification ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Proposed Rule on Changes to Drug Labeling ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Reauthorization of the Prescription Drug User Fee Act ---Special Medical Use/Limited Population Drug ---Use of Real-World Evidence ---S.204 -H.R. 878: Rights to Try Act of 2017 ---S.456 - H.R. 1231: RACE for Children Act ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---Welch Amendment to: H.R. 2430: FDA Reauthorization Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Product Communications ---The Medical Products Communications Act of 2017 (Rep. Griffith Discussion Draft) ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Funding for Antimicrobial Resistance Programs ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Department of Defense Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Orphan Drug Issues ---RACE for Children Act (Discussion Draft) ---Tax Credit ---Technical Amendments ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---H.R. 1628: American Health Care Act ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Foreign Drug Data Protection Laws ---Israel Trade and Foreign Drug Price Controls
Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---The Better Care Reconciliation Act of 2017 (Senate Discussion Drafts) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of Medical Countermeasures Innovation Act ---Tropical Disease Priority Review Voucher (PRV) Program ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Patent Certification ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Proposed Rule on Changes to Drug Labeling ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Reauthorization of the Prescription Drug User Fee Act ---Special Medical Use/Limited Population Drug ---Use of Real-World Evidence ---S.204 -H.R. 878: Rights to Try Act of 2017 ---S.456 - H.R. 1231: RACE for Children Act ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---Welch Amendment to: H.R. 2430: FDA Reauthorization Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Product Communications ---The Medical Products Communications Act of 2017 (Rep. Griffith Discussion Draft) ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Funding for Antimicrobial Resistance Programs ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Department of Defense Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Orphan Drug Issues ---RACE for Children Act (Discussion Draft) ---Tax Credit ---Technical Amendments ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---H.R. 1628: American Health Care Act ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Foreign Drug Data Protection Laws ---Israel Trade and Foreign Drug Price Controls
Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases
Increasing Competition in Pharmaceuticals Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases
Small Business Capital Formation Enhancement Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Market Enhancements ---Accredited Investor definition ---SEC Small Business Forum ---SEC Rule 701 ---PCAOB Audit Cost Increases ---Fair Investment Opportunities for Professional Experts Act (House Discussion Draft) ---H.R. 1343/S.488: Encouraging Employee Ownership Act ---H.R. 1312/S.416: Small Business Capital Formation Enhancement Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) Proxy Advisory Services ---Impact of Policies on Small Public Companies ---Corporate Governance Reform and Transparency Act (House Discussion Draft) ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---Accredited Investor Certification ---Financial CHOICE Act (House Discussion Draft) ---H.R. 79/S. 588: HALOS Act Sarbanes Oxley Section 404 (b) ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1645: Fostering Innovation Act Short Selling Transparency Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---Small Company Disclosure Simplification Act (House Discussion Draft)
Small Business Capital Formation Enhancement Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Market Enhancements ---Accredited Investor Definition ---Fair Investment Opportunities for Professional Experts Act (House Discussion Draft) ---H.R. 1312/S.416: Small Business Capital Formation Enhancement Act ---H.R. 1343/S.488: Encouraging Employee Ownership Act ---SEC Rule 701 ---SEC Small Business Forum Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---H.R. 10: Financial CHOICE Act Proxy Advisory Services ---Corporate Governance Reform and Transparency Act (House Discussion Draft) ---H.R. 10: Financial CHOICE Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Accredited Investor Certification ---H.R. 10: Financial CHOICE Act ---H.R. 79/S. 588: HALOS Act Sarbanes Oxley Section 404 (b) ---H.R. 10: Financial CHOICE Act ---H.R. 1645: Fostering Innovation Act ---Small Issuer Exemption Short Selling Transparency XBRL Exemption for Small Public Companies ---H.R. 10: Financial CHOICE Act ---Small Company Disclosure Simplification Act (House Discussion Draft)
RACE for Children Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---The Better Care Reconciliation Act of 2017 (Senate Discussion Drafts) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of Medical Countermeasures Innovation Act ---Tropical Disease Priority Review Voucher (PRV) Program ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Patent Certification ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Proposed Rule on Changes to Drug Labeling ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Reauthorization of the Prescription Drug User Fee Act ---Special Medical Use/Limited Population Drug ---Use of Real-World Evidence ---S.204 -H.R. 878: Rights to Try Act of 2017 ---S.456 - H.R. 1231: RACE for Children Act ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---Welch Amendment to: H.R. 2430: FDA Reauthorization Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Product Communications ---The Medical Products Communications Act of 2017 (Rep. Griffith Discussion Draft) ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Funding for Antimicrobial Resistance Programs ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Department of Defense Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Orphan Drug Issues ---RACE for Children Act (Discussion Draft) ---Tax Credit ---Technical Amendments ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---H.R. 1628: American Health Care Act ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Foreign Drug Data Protection Laws ---Israel Trade and Foreign Drug Price Controls
Affordable and Safe Prescription Drug Importation Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---The Better Care Reconciliation Act of 2017 (Senate Discussion Drafts) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of Medical Countermeasures Innovation Act ---Tropical Disease Priority Review Voucher (PRV) Program ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Patent Certification ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Proposed Rule on Changes to Drug Labeling ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Reauthorization of the Prescription Drug User Fee Act ---Special Medical Use/Limited Population Drug ---Use of Real-World Evidence ---S.204 -H.R. 878: Rights to Try Act of 2017 ---S.456 - H.R. 1231: RACE for Children Act ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---Welch Amendment to: H.R. 2430: FDA Reauthorization Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Product Communications ---The Medical Products Communications Act of 2017 (Rep. Griffith Discussion Draft) ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Funding for Antimicrobial Resistance Programs ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Department of Defense Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Orphan Drug Issues ---RACE for Children Act (Discussion Draft) ---Tax Credit ---Technical Amendments ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---H.R. 1628: American Health Care Act ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Foreign Drug Data Protection Laws ---Israel Trade and Foreign Drug Price Controls
Affordable and Safe Prescription Drug Importation Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases
JOBS and Investor Confidence Act of 2018
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Market Enhancements ---Accredited Investor definition ---SEC Small Business Forum ---SEC Rule 701 ---PCAOB Audit Cost Increases ---Fair Investment Opportunities for Professional Experts Act (House Discussion Draft) ---H.R. 1343/S.488: Encouraging Employee Ownership Act ---H.R. 1312/S.416: Small Business Capital Formation Enhancement Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) Proxy Advisory Services ---Impact of Policies on Small Public Companies ---Corporate Governance Reform and Transparency Act (House Discussion Draft) ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---Accredited Investor Certification ---Financial CHOICE Act (House Discussion Draft) ---H.R. 79/S. 588: HALOS Act Sarbanes Oxley Section 404 (b) ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1645: Fostering Innovation Act Short Selling Transparency Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---Small Company Disclosure Simplification Act (House Discussion Draft)
JOBS and Investor Confidence Act of 2018
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Market Enhancements ---Accredited Investor Definition ---Fair Investment Opportunities for Professional Experts Act (House Discussion Draft) ---H.R. 1312/S.416: Small Business Capital Formation Enhancement Act ---H.R. 1343/S.488: Encouraging Employee Ownership Act ---SEC Rule 701 ---SEC Small Business Forum Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---H.R. 10: Financial CHOICE Act Proxy Advisory Services ---Corporate Governance Reform and Transparency Act (House Discussion Draft) ---H.R. 10: Financial CHOICE Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Accredited Investor Certification ---H.R. 10: Financial CHOICE Act ---H.R. 79/S. 588: HALOS Act Sarbanes Oxley Section 404 (b) ---H.R. 10: Financial CHOICE Act ---H.R. 1645: Fostering Innovation Act ---Small Issuer Exemption Short Selling Transparency XBRL Exemption for Small Public Companies ---H.R. 10: Financial CHOICE Act ---Small Company Disclosure Simplification Act (House Discussion Draft)
HALOS Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Market Enhancements ---Accredited Investor Definition ---Fair Investment Opportunities for Professional Experts Act (House Discussion Draft) ---H.R. 1312/S.416: Small Business Capital Formation Enhancement Act ---H.R. 1343/S.488: Encouraging Employee Ownership Act ---SEC Rule 701 ---SEC Small Business Forum Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---H.R. 10: Financial CHOICE Act Proxy Advisory Services ---Corporate Governance Reform and Transparency Act (House Discussion Draft) ---H.R. 10: Financial CHOICE Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Accredited Investor Certification ---H.R. 10: Financial CHOICE Act ---H.R. 79/S. 588: HALOS Act Sarbanes Oxley Section 404 (b) ---H.R. 10: Financial CHOICE Act ---H.R. 1645: Fostering Innovation Act ---Small Issuer Exemption Short Selling Transparency XBRL Exemption for Small Public Companies ---H.R. 10: Financial CHOICE Act ---Small Company Disclosure Simplification Act (House Discussion Draft)
HALOS Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Market Enhancements ---Accredited Investor definition ---SEC Small Business Forum ---SEC Rule 701 ---PCAOB Audit Cost Increases ---Fair Investment Opportunities for Professional Experts Act (House Discussion Draft) ---H.R. 1343/S.488: Encouraging Employee Ownership Act ---H.R. 1312/S.416: Small Business Capital Formation Enhancement Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) Proxy Advisory Services ---Impact of Policies on Small Public Companies ---Corporate Governance Reform and Transparency Act (House Discussion Draft) ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---Accredited Investor Certification ---Financial CHOICE Act (House Discussion Draft) ---H.R. 79/S. 588: HALOS Act Sarbanes Oxley Section 404 (b) ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1645: Fostering Innovation Act Short Selling Transparency Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---Small Company Disclosure Simplification Act (House Discussion Draft)
Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases
Improving Access To Affordable Prescription Drugs Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases
Improving Access To Affordable Prescription Drugs Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---The Better Care Reconciliation Act of 2017 (Senate Discussion Drafts) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of Medical Countermeasures Innovation Act ---Tropical Disease Priority Review Voucher (PRV) Program ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Patent Certification ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Proposed Rule on Changes to Drug Labeling ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Reauthorization of the Prescription Drug User Fee Act ---Special Medical Use/Limited Population Drug ---Use of Real-World Evidence ---S.204 -H.R. 878: Rights to Try Act of 2017 ---S.456 - H.R. 1231: RACE for Children Act ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---Welch Amendment to: H.R. 2430: FDA Reauthorization Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Product Communications ---The Medical Products Communications Act of 2017 (Rep. Griffith Discussion Draft) ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Funding for Antimicrobial Resistance Programs ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Department of Defense Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Orphan Drug Issues ---RACE for Children Act (Discussion Draft) ---Tax Credit ---Technical Amendments ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---H.R. 1628: American Health Care Act ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Foreign Drug Data Protection Laws ---Israel Trade and Foreign Drug Price Controls
FDA Reauthorization Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---The Better Care Reconciliation Act of 2017 (Senate Discussion Drafts) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of Medical Countermeasures Innovation Act ---Tropical Disease Priority Review Voucher (PRV) Program ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Patent Certification ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Proposed Rule on Changes to Drug Labeling ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Reauthorization of the Prescription Drug User Fee Act ---Special Medical Use/Limited Population Drug ---Use of Real-World Evidence ---S.204 -H.R. 878: Rights to Try Act of 2017 ---S.456 - H.R. 1231: RACE for Children Act ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---Welch Amendment to: H.R. 2430: FDA Reauthorization Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Product Communications ---The Medical Products Communications Act of 2017 (Rep. Griffith Discussion Draft) ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Funding for Antimicrobial Resistance Programs ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Department of Defense Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Orphan Drug Issues ---RACE for Children Act (Discussion Draft) ---Tax Credit ---Technical Amendments ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---H.R. 1628: American Health Care Act ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Foreign Drug Data Protection Laws ---Israel Trade and Foreign Drug Price Controls
Creating and Restoring Equal Access to Equivalent Samples Act of 2018
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---The Better Care Reconciliation Act of 2017 (Senate Discussion Drafts) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of Medical Countermeasures Innovation Act ---Tropical Disease Priority Review Voucher (PRV) Program ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Patent Certification ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Proposed Rule on Changes to Drug Labeling ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Reauthorization of the Prescription Drug User Fee Act ---Special Medical Use/Limited Population Drug ---Use of Real-World Evidence ---S.204 -H.R. 878: Rights to Try Act of 2017 ---S.456 - H.R. 1231: RACE for Children Act ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S.469: Affordable and Safe Prescription Drug Importation Act ---Welch Amendment to: H.R. 2430: FDA Reauthorization Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Drug Product Communications ---The Medical Products Communications Act of 2017 (Rep. Griffith Discussion Draft) ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Funding for Antimicrobial Resistance Programs ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Department of Defense Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act ---H.R. 749: Lower Drug Costs through Competition Act ---S. 974/H.R. 2212: CREATES Act of 2017 ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Orphan Drug Issues ---RACE for Children Act (Discussion Draft) ---Tax Credit ---Technical Amendments ---S.934/H.R. 2430: FDA Reauthorization Act of 2017 Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S. 771: Improving Access to Affordable Prescription Drugs ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---H.R. 1628: American Health Care Act ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Foreign Drug Data Protection Laws ---Israel Trade and Foreign Drug Price Controls
A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases
Drug Quality and Security Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases
Capital Markets Improvement Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Sarbanes Oxley Section 404 (b) --PCAOB Audit Cost Increases --H.R. 4139: Fostering Innovation Act XBRL Exemption for Small Public Companies --H.R. 1965: Small Company Disclosure Simplification Act --H.R. 1675: Capital Markets Improvement Act Capital Market Enhancements --H.R. 1675: Encouraging Employee Ownership Act --H.R. 4168: Small Business Capital Formation Enhancement Act --H.R. 3784: Securities & Exchange Commission Small Business Advocate Act --H.R. 1675: Capital Markets Improvement Act --H.R. 2354: Streamlining Excessive and Costly Regulations Review Act --H.R. 4638: Main Street Growth Act Proxy Advisory Services --Impact of Policies on Small Public Companies --Proxy Advisory Firm Reform Act (Discussion Draft) Reform of SEC Regulation D --S. 978/H.R. 4498: HALOS Act Short Selling Transparency Capital Formation Investment Incentives --H.R. 2179: PARTNER Act --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act
Capital Markets Improvement Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---Financial CHOICE Act (House Discussion Draft) Small Business Innovation Research (SBIR) Program Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 5311: The Corporate Governance Reform and Transparency Act of 2016 ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---H.R. 4498/S.978: HALOS Act ---H.R. 4852: Private Placement Improvement Act ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) Short Selling Transparency ---H.R.5485/S.3067: Financial Services and General Government Appropriations for FY 2017 XBRL Exemption for Small Public Companies ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act ---Financial CHOICE Act (House Discussion Draft) Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions
Capital Markets Improvement Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act ---H.R. 2179: PARTNER Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 6427: Creating Financial Prosperity for Businesses and Investors Act ---PCAOB Audit Cost Increases Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4498/S. 978: HALOS Act Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act
Small Company Disclosure Simplification Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---PCAOB Audit Cost Increases Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1965: Small Company Disclosure Simplification Act
Small Company Disclosure Simplification Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act ---H.R. 2179: PARTNER Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 6427: Creating Financial Prosperity for Businesses and Investors Act ---PCAOB Audit Cost Increases Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4498/S. 978: HALOS Act Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act
Small Company Disclosure Simplification Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---Financial CHOICE Act (House Discussion Draft) Small Business Innovation Research (SBIR) Program Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 5311: The Corporate Governance Reform and Transparency Act of 2016 ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---H.R. 4498/S.978: HALOS Act ---H.R. 4852: Private Placement Improvement Act ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) Short Selling Transparency ---H.R.5485/S.3067: Financial Services and General Government Appropriations for FY 2017 XBRL Exemption for Small Public Companies ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act ---Financial CHOICE Act (House Discussion Draft) Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions
Small Company Disclosure Simplification Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Sarbanes Oxley Section 404 (b) --PCAOB Audit Cost Increases --H.R. 4139: Fostering Innovation Act XBRL Exemption for Small Public Companies --H.R. 1965: Small Company Disclosure Simplification Act --H.R. 1675: Capital Markets Improvement Act Capital Market Enhancements --H.R. 1675: Encouraging Employee Ownership Act --H.R. 4168: Small Business Capital Formation Enhancement Act --H.R. 3784: Securities & Exchange Commission Small Business Advocate Act --H.R. 1675: Capital Markets Improvement Act --H.R. 2354: Streamlining Excessive and Costly Regulations Review Act --H.R. 4638: Main Street Growth Act Proxy Advisory Services --Impact of Policies on Small Public Companies --Proxy Advisory Firm Reform Act (Discussion Draft) Reform of SEC Regulation D --S. 978/H.R. 4498: HALOS Act Short Selling Transparency Capital Formation Investment Incentives --H.R. 2179: PARTNER Act --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act
Consolidated Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures/ Senate Innovation for Healthier Americans ---H.R.34: 21st Century Cures Act ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---S. 524: Comprehensive Addiction and Recovery Act of 2016 ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---S. 3239/H.R. 5858: RACE for Children Act 340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 ---CREATES Act (House Energy & Commerce Committee Discussion Draft) Drug Evaluation and Review ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---CREATES Act (House Energy & Commerce Committee Discussion Draft) ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Independent Payment Advisory Board Orphan Drug Act Tax Credit Precision Medicine Initiative Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part B Physician-Administered Products ---Value-based Contracting and Communications TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---H.R. 3299: Strengthening Public Health Emergency Response Act ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---Supplemental Funding for Combating Zika ---Vaccine Injury Compensation Program ---Vaccine Safety
PARTNER Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---Production Tax Credit Extension Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---H.R. 2179: PARTNER Act ---S. 537: COMPETE Act Inversions ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Treatment of Financial Interests as Stock or Indebtedness ---Section 385 Proposed Regulations Orphan Drug Act Tax Credit No sub-issues Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---New Production Tax Credit ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---S. 2271: The Renewable Chemical Production Tax Credit Act
PARTNER Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Sarbanes Oxley Section 404 (b) --PCAOB Audit Cost Increases --H.R. 4139: Fostering Innovation Act XBRL Exemption for Small Public Companies --H.R. 1965: Small Company Disclosure Simplification Act --H.R. 1675: Capital Markets Improvement Act Capital Market Enhancements --H.R. 1675: Encouraging Employee Ownership Act --H.R. 4168: Small Business Capital Formation Enhancement Act --H.R. 3784: Securities & Exchange Commission Small Business Advocate Act --H.R. 1675: Capital Markets Improvement Act --H.R. 2354: Streamlining Excessive and Costly Regulations Review Act --H.R. 4638: Main Street Growth Act Proxy Advisory Services --Impact of Policies on Small Public Companies --Proxy Advisory Firm Reform Act (Discussion Draft) Reform of SEC Regulation D --S. 978/H.R. 4498: HALOS Act Short Selling Transparency Capital Formation Investment Incentives --H.R. 2179: PARTNER Act --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act
PARTNER Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---PCAOB Audit Cost Increases Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1965: Small Company Disclosure Simplification Act
PARTNER Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act ---H.R. 2179: PARTNER Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 6427: Creating Financial Prosperity for Businesses and Investors Act ---PCAOB Audit Cost Increases Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4498/S. 978: HALOS Act Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act
PARTNER Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) --Production Tax Credit Extension --S. 2658: Federal Aviation Administration Reauthorization Act of 2016 ----Franken-Grassley Amendment Research & Development Tax Credit Reforms --Extension --Permanency --Refundable R&D Credit Capital Formation Investment Incentives --H.R. 2179: PARTNER Act --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act Tax Reform --Innovation Box / Patent Box Orphan Drug Act Tax Credit Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act Inversions --Financial Services and General Government Appropriations Act for FY 2017 Renewable Chemicals/Bio-based Products (Non-Funding) --Investment Tax Credit for Renewable Chemicals and Bio-based Products --S. 2271: The Renewable Chemicals Act --S. 1656/H.R. 2883: Master Limited Partnership Parity Act --H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act  
PARTNER Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Inversions ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Orphan Drug Act Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---New Production Tax Credit ---S. 2271: The Renewable Chemical Production Tax Credit Act Research & Development Tax Credit Reforms ---Refundable R&D Credit
PARTNER Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biofuels (Non-Funding) ---Production Tax Credit Extension Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Inversions ---Treatment of Financial Interests as Stock or Indebtedness: Section 385 Proposed Regulations Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---S. 2271: The Renewable Chemical Production Tax Credit Act ---S. 1656/H.R. 2883: Master Limited Partnership Parity Act ---Expansion of Master Limited Partnerships to Renewable Chemicals Research & Development Tax Credit Reforms ---Extension ---H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities ---Permanency ---Refundable R&D Credit ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Orphan Drug Tax Credit
PARTNER Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---Financial CHOICE Act (House Discussion Draft) Small Business Innovation Research (SBIR) Program Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 5311: The Corporate Governance Reform and Transparency Act of 2016 ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---H.R. 4498/S.978: HALOS Act ---H.R. 4852: Private Placement Improvement Act ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) Short Selling Transparency ---H.R.5485/S.3067: Financial Services and General Government Appropriations for FY 2017 XBRL Exemption for Small Public Companies ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act ---Financial CHOICE Act (House Discussion Draft) Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions
Fair Investment Opportunities for Professional Experts Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---Financial CHOICE Act (House Discussion Draft) Small Business Innovation Research (SBIR) Program Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 5311: The Corporate Governance Reform and Transparency Act of 2016 ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---H.R. 4498/S.978: HALOS Act ---H.R. 4852: Private Placement Improvement Act ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) Short Selling Transparency ---H.R.5485/S.3067: Financial Services and General Government Appropriations for FY 2017 XBRL Exemption for Small Public Companies ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act ---Financial CHOICE Act (House Discussion Draft) Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions
Fair Investment Opportunities for Professional Experts Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act ---H.R. 2179: PARTNER Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 6427: Creating Financial Prosperity for Businesses and Investors Act ---PCAOB Audit Cost Increases Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4498/S. 978: HALOS Act Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act
Streamlining Excessive and Costly Regulations Review Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---Financial CHOICE Act (House Discussion Draft) Small Business Innovation Research (SBIR) Program Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 5311: The Corporate Governance Reform and Transparency Act of 2016 ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---H.R. 4498/S.978: HALOS Act ---H.R. 4852: Private Placement Improvement Act ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) Short Selling Transparency ---H.R.5485/S.3067: Financial Services and General Government Appropriations for FY 2017 XBRL Exemption for Small Public Companies ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act ---Financial CHOICE Act (House Discussion Draft) Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions
Streamlining Excessive and Costly Regulations Review Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act ---H.R. 2179: PARTNER Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 6427: Creating Financial Prosperity for Businesses and Investors Act ---PCAOB Audit Cost Increases Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4498/S. 978: HALOS Act Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act
Streamlining Excessive and Costly Regulations Review Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Sarbanes Oxley Section 404 (b) --PCAOB Audit Cost Increases --H.R. 4139: Fostering Innovation Act XBRL Exemption for Small Public Companies --H.R. 1965: Small Company Disclosure Simplification Act --H.R. 1675: Capital Markets Improvement Act Capital Market Enhancements --H.R. 1675: Encouraging Employee Ownership Act --H.R. 4168: Small Business Capital Formation Enhancement Act --H.R. 3784: Securities & Exchange Commission Small Business Advocate Act --H.R. 1675: Capital Markets Improvement Act --H.R. 2354: Streamlining Excessive and Costly Regulations Review Act --H.R. 4638: Main Street Growth Act Proxy Advisory Services --Impact of Policies on Small Public Companies --Proxy Advisory Firm Reform Act (Discussion Draft) Reform of SEC Regulation D --S. 978/H.R. 4498: HALOS Act Short Selling Transparency Capital Formation Investment Incentives --H.R. 2179: PARTNER Act --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act
Accelerating Access to Capital Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act ---H.R. 2179: PARTNER Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 6427: Creating Financial Prosperity for Businesses and Investors Act ---PCAOB Audit Cost Increases Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4498/S. 978: HALOS Act Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act
Accelerating Access to Capital Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---Financial CHOICE Act (House Discussion Draft) Small Business Innovation Research (SBIR) Program Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 5311: The Corporate Governance Reform and Transparency Act of 2016 ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---H.R. 4498/S.978: HALOS Act ---H.R. 4852: Private Placement Improvement Act ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) Short Selling Transparency ---H.R.5485/S.3067: Financial Services and General Government Appropriations for FY 2017 XBRL Exemption for Small Public Companies ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act ---Financial CHOICE Act (House Discussion Draft) Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions
Master Limited Partnerships Parity Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biofuels (Non-Funding) ---Production Tax Credit Extension Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Inversions ---Treatment of Financial Interests as Stock or Indebtedness: Section 385 Proposed Regulations Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---S. 2271: The Renewable Chemical Production Tax Credit Act ---S. 1656/H.R. 2883: Master Limited Partnership Parity Act ---Expansion of Master Limited Partnerships to Renewable Chemicals Research & Development Tax Credit Reforms ---Extension ---H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities ---Permanency ---Refundable R&D Credit ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Orphan Drug Tax Credit
Master Limited Partnerships Parity Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) --Production Tax Credit Extension --S. 2658: Federal Aviation Administration Reauthorization Act of 2016 ----Franken-Grassley Amendment Research & Development Tax Credit Reforms --Extension --Permanency --Refundable R&D Credit Capital Formation Investment Incentives --H.R. 2179: PARTNER Act --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act Tax Reform --Innovation Box / Patent Box Orphan Drug Act Tax Credit Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act Inversions --Financial Services and General Government Appropriations Act for FY 2017 Renewable Chemicals/Bio-based Products (Non-Funding) --Investment Tax Credit for Renewable Chemicals and Bio-based Products --S. 2271: The Renewable Chemicals Act --S. 1656/H.R. 2883: Master Limited Partnership Parity Act --H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act  
Strengthening Public Health Emergency Response Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures/ Senate Innovation for Healthier Americans ---H.R.34: 21st Century Cures Act ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---S. 524: Comprehensive Addiction and Recovery Act of 2016 ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---S. 3239/H.R. 5858: RACE for Children Act 340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 ---CREATES Act (House Energy & Commerce Committee Discussion Draft) Drug Evaluation and Review ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---CREATES Act (House Energy & Commerce Committee Discussion Draft) ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Independent Payment Advisory Board Orphan Drug Act Tax Credit Precision Medicine Initiative Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part B Physician-Administered Products ---Value-based Contracting and Communications TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---H.R. 3299: Strengthening Public Health Emergency Response Act ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---Supplemental Funding for Combating Zika ---Vaccine Injury Compensation Program ---Vaccine Safety
Qualifying Renewable Chemical Production or Investment Tax Credit Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---Production Tax Credit Extension Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---H.R. 2179: PARTNER Act ---S. 537: COMPETE Act Inversions ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Treatment of Financial Interests as Stock or Indebtedness ---Section 385 Proposed Regulations Orphan Drug Act Tax Credit No sub-issues Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---New Production Tax Credit ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---S. 2271: The Renewable Chemical Production Tax Credit Act
Qualifying Renewable Chemical Production or Investment Tax Credit Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biofuels (Non-Funding) ---Production Tax Credit Extension Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Inversions ---Treatment of Financial Interests as Stock or Indebtedness: Section 385 Proposed Regulations Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---S. 2271: The Renewable Chemical Production Tax Credit Act ---S. 1656/H.R. 2883: Master Limited Partnership Parity Act ---Expansion of Master Limited Partnerships to Renewable Chemicals Research & Development Tax Credit Reforms ---Extension ---H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities ---Permanency ---Refundable R&D Credit ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Orphan Drug Tax Credit
Qualifying Renewable Chemical Production or Investment Tax Credit Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) --Production Tax Credit Extension --S. 2658: Federal Aviation Administration Reauthorization Act of 2016 ----Franken-Grassley Amendment Research & Development Tax Credit Reforms --Extension --Permanency --Refundable R&D Credit Capital Formation Investment Incentives --H.R. 2179: PARTNER Act --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act Tax Reform --Innovation Box / Patent Box Orphan Drug Act Tax Credit Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act Inversions --Financial Services and General Government Appropriations Act for FY 2017 Renewable Chemicals/Bio-based Products (Non-Funding) --Investment Tax Credit for Renewable Chemicals and Bio-based Products --S. 2271: The Renewable Chemicals Act --S. 1656/H.R. 2883: Master Limited Partnership Parity Act --H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act  
Qualifying Renewable Chemical Production or Investment Tax Credit Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Inversions ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Orphan Drug Act Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---New Production Tax Credit ---S. 2271: The Renewable Chemical Production Tax Credit Act Research & Development Tax Credit Reforms ---Refundable R&D Credit
21st Century Cures Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures/ Senate Innovation for Healthier Americans ---H.R.34: 21st Century Cures Act ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---S. 524: Comprehensive Addiction and Recovery Act of 2016 ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---S. 3239/H.R. 5858: RACE for Children Act 340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 ---CREATES Act (House Energy & Commerce Committee Discussion Draft) Drug Evaluation and Review ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---CREATES Act (House Energy & Commerce Committee Discussion Draft) ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Independent Payment Advisory Board Orphan Drug Act Tax Credit Precision Medicine Initiative Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part B Physician-Administered Products ---Value-based Contracting and Communications TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---H.R. 3299: Strengthening Public Health Emergency Response Act ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---Supplemental Funding for Combating Zika ---Vaccine Injury Compensation Program ---Vaccine Safety
Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biofuels (Non-Funding) ---Production Tax Credit Extension Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Inversions ---Treatment of Financial Interests as Stock or Indebtedness: Section 385 Proposed Regulations Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---S. 2271: The Renewable Chemical Production Tax Credit Act ---S. 1656/H.R. 2883: Master Limited Partnership Parity Act ---Expansion of Master Limited Partnerships to Renewable Chemicals Research & Development Tax Credit Reforms ---Extension ---H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities ---Permanency ---Refundable R&D Credit ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Orphan Drug Tax Credit
Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) --Production Tax Credit Extension --S. 2658: Federal Aviation Administration Reauthorization Act of 2016 ----Franken-Grassley Amendment Research & Development Tax Credit Reforms --Extension --Permanency --Refundable R&D Credit Capital Formation Investment Incentives --H.R. 2179: PARTNER Act --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act Tax Reform --Innovation Box / Patent Box Orphan Drug Act Tax Credit Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act Inversions --Financial Services and General Government Appropriations Act for FY 2017 Renewable Chemicals/Bio-based Products (Non-Funding) --Investment Tax Credit for Renewable Chemicals and Bio-based Products --S. 2271: The Renewable Chemicals Act --S. 1656/H.R. 2883: Master Limited Partnership Parity Act --H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act  
Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Inversions ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Orphan Drug Act Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---New Production Tax Credit ---S. 2271: The Renewable Chemical Production Tax Credit Act Research & Development Tax Credit Reforms ---Refundable R&D Credit
Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Coding --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Patent Certification --Brazil Biologics Regulations Funding for National Institutes of Health --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for Centers for Disease Control and Prevention Vaccine Programs --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 340B Drug Pricing Program --Implementation of Affordable Care Act --Program Implementation & Oversight --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Drug Importation --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Biodefense Research, Development and Procurement Issues (Nonfunding) Reimbursement for Innovative Products --Medicare Part B Physician-Administered Products --Medicare Part D Prescription Drug Program: ----CMS Proposed Rule on Protected Classes --Value-based Contracting and Communications Drug Evaluation and Review --Compassionate Use/Expanded Access --FDA Proposed Rule on Changes to Drug Labeling --Implementation of the FDA Safety and Innovation Act --Reauthorization of the Prescription Drug User Fee Act --Special Medical Use/Limited Population Drug ---- ADAPT Act (House Discussion Draft) Senate Innovation for Healthier Americans --Biomarkers and Regulatory Science Improvements --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives ----S. 195: PATH Act --Communication with Healthcare Professionals and Payors --Priority Review Voucher Programs Priority Review of Generic Drugs ----S. 2615: Increasing Competition in Pharmaceuticals Act Vaccines and Infectious Diseases - General Government Price Reporting --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Gene Editing Technologies --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act Drug Manufacturing, Quality & Distribution --Supply Chain Integrity and Traceability Affordable Care Act Implementation --Third Party Support of Patient Premiums and Cost-Sharing Obligations Combating Antibiotic-Resistant Bacteria (CARB) Initiative Vaccine Access/Financing --Adult Immunization (Senate Discussion Draft) --Implementation of Affordable Care Act --Senate Chronic Care Working Group Proposals --Vaccine Injury Compensation Program TransPacific Partnership --Data and Intellectual Property Protection for Pharmaceuticals --Reimbursement Transparency Orphan Drug Act Tax Credit UN Commission on Access to Medicines
SEC Small Business Advocate Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---Financial CHOICE Act (House Discussion Draft) Small Business Innovation Research (SBIR) Program Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 5311: The Corporate Governance Reform and Transparency Act of 2016 ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---H.R. 4498/S.978: HALOS Act ---H.R. 4852: Private Placement Improvement Act ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) Short Selling Transparency ---H.R.5485/S.3067: Financial Services and General Government Appropriations for FY 2017 XBRL Exemption for Small Public Companies ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act ---Financial CHOICE Act (House Discussion Draft) Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions
SEC Small Business Advocate Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act ---H.R. 2179: PARTNER Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 6427: Creating Financial Prosperity for Businesses and Investors Act ---PCAOB Audit Cost Increases Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4498/S. 978: HALOS Act Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act
SEC Small Business Advocate Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Sarbanes Oxley Section 404 (b) --PCAOB Audit Cost Increases --H.R. 4139: Fostering Innovation Act XBRL Exemption for Small Public Companies --H.R. 1965: Small Company Disclosure Simplification Act --H.R. 1675: Capital Markets Improvement Act Capital Market Enhancements --H.R. 1675: Encouraging Employee Ownership Act --H.R. 4168: Small Business Capital Formation Enhancement Act --H.R. 3784: Securities & Exchange Commission Small Business Advocate Act --H.R. 1675: Capital Markets Improvement Act --H.R. 2354: Streamlining Excessive and Costly Regulations Review Act --H.R. 4638: Main Street Growth Act Proxy Advisory Services --Impact of Policies on Small Public Companies --Proxy Advisory Firm Reform Act (Discussion Draft) Reform of SEC Regulation D --S. 978/H.R. 4498: HALOS Act Short Selling Transparency Capital Formation Investment Incentives --H.R. 2179: PARTNER Act --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act
SEC Small Business Advocate Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---PCAOB Audit Cost Increases Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1965: Small Company Disclosure Simplification Act
Fostering Innovation Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---Financial CHOICE Act (House Discussion Draft) Small Business Innovation Research (SBIR) Program Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 5311: The Corporate Governance Reform and Transparency Act of 2016 ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---H.R. 4498/S.978: HALOS Act ---H.R. 4852: Private Placement Improvement Act ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) Short Selling Transparency ---H.R.5485/S.3067: Financial Services and General Government Appropriations for FY 2017 XBRL Exemption for Small Public Companies ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act ---Financial CHOICE Act (House Discussion Draft) Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions
Fostering Innovation Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act ---H.R. 2179: PARTNER Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 6427: Creating Financial Prosperity for Businesses and Investors Act ---PCAOB Audit Cost Increases Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4498/S. 978: HALOS Act Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act
Fostering Innovation Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Sarbanes Oxley Section 404 (b) --PCAOB Audit Cost Increases --H.R. 4139: Fostering Innovation Act XBRL Exemption for Small Public Companies --H.R. 1965: Small Company Disclosure Simplification Act --H.R. 1675: Capital Markets Improvement Act Capital Market Enhancements --H.R. 1675: Encouraging Employee Ownership Act --H.R. 4168: Small Business Capital Formation Enhancement Act --H.R. 3784: Securities & Exchange Commission Small Business Advocate Act --H.R. 1675: Capital Markets Improvement Act --H.R. 2354: Streamlining Excessive and Costly Regulations Review Act --H.R. 4638: Main Street Growth Act Proxy Advisory Services --Impact of Policies on Small Public Companies --Proxy Advisory Firm Reform Act (Discussion Draft) Reform of SEC Regulation D --S. 978/H.R. 4498: HALOS Act Short Selling Transparency Capital Formation Investment Incentives --H.R. 2179: PARTNER Act --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act
Fostering Innovation Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---PCAOB Audit Cost Increases Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1965: Small Company Disclosure Simplification Act
Small Business Capital Formation Enhancement Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act ---H.R. 2179: PARTNER Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 6427: Creating Financial Prosperity for Businesses and Investors Act ---PCAOB Audit Cost Increases Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4498/S. 978: HALOS Act Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act
Small Business Capital Formation Enhancement Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---PCAOB Audit Cost Increases Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1965: Small Company Disclosure Simplification Act
Small Business Capital Formation Enhancement Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---Financial CHOICE Act (House Discussion Draft) Small Business Innovation Research (SBIR) Program Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 5311: The Corporate Governance Reform and Transparency Act of 2016 ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---H.R. 4498/S.978: HALOS Act ---H.R. 4852: Private Placement Improvement Act ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) Short Selling Transparency ---H.R.5485/S.3067: Financial Services and General Government Appropriations for FY 2017 XBRL Exemption for Small Public Companies ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act ---Financial CHOICE Act (House Discussion Draft) Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions
Small Business Capital Formation Enhancement Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Sarbanes Oxley Section 404 (b) --PCAOB Audit Cost Increases --H.R. 4139: Fostering Innovation Act XBRL Exemption for Small Public Companies --H.R. 1965: Small Company Disclosure Simplification Act --H.R. 1675: Capital Markets Improvement Act Capital Market Enhancements --H.R. 1675: Encouraging Employee Ownership Act --H.R. 4168: Small Business Capital Formation Enhancement Act --H.R. 3784: Securities & Exchange Commission Small Business Advocate Act --H.R. 1675: Capital Markets Improvement Act --H.R. 2354: Streamlining Excessive and Costly Regulations Review Act --H.R. 4638: Main Street Growth Act Proxy Advisory Services --Impact of Policies on Small Public Companies --Proxy Advisory Firm Reform Act (Discussion Draft) Reform of SEC Regulation D --S. 978/H.R. 4498: HALOS Act Short Selling Transparency Capital Formation Investment Incentives --H.R. 2179: PARTNER Act --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act
Helping Angels Lead Our Startups Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Sarbanes Oxley Section 404 (b) --PCAOB Audit Cost Increases --H.R. 4139: Fostering Innovation Act XBRL Exemption for Small Public Companies --H.R. 1965: Small Company Disclosure Simplification Act --H.R. 1675: Capital Markets Improvement Act Capital Market Enhancements --H.R. 1675: Encouraging Employee Ownership Act --H.R. 4168: Small Business Capital Formation Enhancement Act --H.R. 3784: Securities & Exchange Commission Small Business Advocate Act --H.R. 1675: Capital Markets Improvement Act --H.R. 2354: Streamlining Excessive and Costly Regulations Review Act --H.R. 4638: Main Street Growth Act Proxy Advisory Services --Impact of Policies on Small Public Companies --Proxy Advisory Firm Reform Act (Discussion Draft) Reform of SEC Regulation D --S. 978/H.R. 4498: HALOS Act Short Selling Transparency Capital Formation Investment Incentives --H.R. 2179: PARTNER Act --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act
Helping Angels Lead Our Startups Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act ---H.R. 2179: PARTNER Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 6427: Creating Financial Prosperity for Businesses and Investors Act ---PCAOB Audit Cost Increases Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4498/S. 978: HALOS Act Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act
Helping Angels Lead Our Startups Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---Financial CHOICE Act (House Discussion Draft) Small Business Innovation Research (SBIR) Program Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 5311: The Corporate Governance Reform and Transparency Act of 2016 ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---H.R. 4498/S.978: HALOS Act ---H.R. 4852: Private Placement Improvement Act ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) Short Selling Transparency ---H.R.5485/S.3067: Financial Services and General Government Appropriations for FY 2017 XBRL Exemption for Small Public Companies ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act ---Financial CHOICE Act (House Discussion Draft) Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions
Main Street Growth Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act ---H.R. 2179: PARTNER Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 6427: Creating Financial Prosperity for Businesses and Investors Act ---PCAOB Audit Cost Increases Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4498/S. 978: HALOS Act Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act
Main Street Growth Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---Financial CHOICE Act (House Discussion Draft) Small Business Innovation Research (SBIR) Program Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 5311: The Corporate Governance Reform and Transparency Act of 2016 ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---H.R. 4498/S.978: HALOS Act ---H.R. 4852: Private Placement Improvement Act ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) Short Selling Transparency ---H.R.5485/S.3067: Financial Services and General Government Appropriations for FY 2017 XBRL Exemption for Small Public Companies ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act ---Financial CHOICE Act (House Discussion Draft) Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions
Main Street Growth Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Sarbanes Oxley Section 404 (b) --PCAOB Audit Cost Increases --H.R. 4139: Fostering Innovation Act XBRL Exemption for Small Public Companies --H.R. 1965: Small Company Disclosure Simplification Act --H.R. 1675: Capital Markets Improvement Act Capital Market Enhancements --H.R. 1675: Encouraging Employee Ownership Act --H.R. 4168: Small Business Capital Formation Enhancement Act --H.R. 3784: Securities & Exchange Commission Small Business Advocate Act --H.R. 1675: Capital Markets Improvement Act --H.R. 2354: Streamlining Excessive and Costly Regulations Review Act --H.R. 4638: Main Street Growth Act Proxy Advisory Services --Impact of Policies on Small Public Companies --Proxy Advisory Firm Reform Act (Discussion Draft) Reform of SEC Regulation D --S. 978/H.R. 4498: HALOS Act Short Selling Transparency Capital Formation Investment Incentives --H.R. 2179: PARTNER Act --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act
REGROW Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures/ Senate Innovation for Healthier Americans ---H.R.34: 21st Century Cures Act ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---S. 524: Comprehensive Addiction and Recovery Act of 2016 ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---S. 3239/H.R. 5858: RACE for Children Act 340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 ---CREATES Act (House Energy & Commerce Committee Discussion Draft) Drug Evaluation and Review ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---CREATES Act (House Energy & Commerce Committee Discussion Draft) ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Independent Payment Advisory Board Orphan Drug Act Tax Credit Precision Medicine Initiative Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part B Physician-Administered Products ---Value-based Contracting and Communications TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---H.R. 3299: Strengthening Public Health Emergency Response Act ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---Supplemental Funding for Combating Zika ---Vaccine Injury Compensation Program ---Vaccine Safety
Private Placement Improvement Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---Financial CHOICE Act (House Discussion Draft) Small Business Innovation Research (SBIR) Program Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 5311: The Corporate Governance Reform and Transparency Act of 2016 ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---H.R. 4498/S.978: HALOS Act ---H.R. 4852: Private Placement Improvement Act ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) Short Selling Transparency ---H.R.5485/S.3067: Financial Services and General Government Appropriations for FY 2017 XBRL Exemption for Small Public Companies ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act ---Financial CHOICE Act (House Discussion Draft) Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions
Capital Market Enhancements ---Accredited Investor Definition ---Fair Investment Opportunities for Professional Experts Act (House Discussion Draft) ---H.R. 1312/S.416: Small Business Capital Formation Enhancement Act ---H.R. 1343/S.488: Encouraging Employee Ownership Act ---SEC Rule 701 ---SEC Small Business Forum Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---H.R. 10: Financial CHOICE Act Proxy Advisory Services ---Corporate Governance Reform and Transparency Act (House Discussion Draft) ---H.R. 10: Financial CHOICE Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Accredited Investor Certification ---H.R. 10: Financial CHOICE Act ---H.R. 79/S. 588: HALOS Act Sarbanes Oxley Section 404 (b) ---H.R. 10: Financial CHOICE Act ---H.R. 1645: Fostering Innovation Act ---Small Issuer Exemption Short Selling Transparency XBRL Exemption for Small Public Companies ---H.R. 10: Financial CHOICE Act ---Small Company Disclosure Simplification Act (House Discussion Draft)
Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension Capital Formation Investment Incentives ---An Act to Modify Net Operating Loss Carryforwards (House Discussion Draft) ---H.R. 2297: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules Orphan Drug Issues ---Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit ---Production Tax Credit ---Expansion of Master Limited Partnerships to Renewable Chemicals ---HR 3149: Renewable Chemicals Act of 2017 Research & Development Tax Credit Reforms ---Refundable R&D Credit Treatment of Financial Interests as Stock or Indebtedness ---Section 385 Proposed Regulations Corporate Tax Reform
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2017 · first_quarter · Q1
21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases
Capital Market Enhancements ---Accredited Investor definition ---SEC Small Business Forum ---SEC Rule 701 ---PCAOB Audit Cost Increases ---Fair Investment Opportunities for Professional Experts Act (House Discussion Draft) ---H.R. 1343/S.488: Encouraging Employee Ownership Act ---H.R. 1312/S.416: Small Business Capital Formation Enhancement Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) Proxy Advisory Services ---Impact of Policies on Small Public Companies ---Corporate Governance Reform and Transparency Act (House Discussion Draft) ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---Accredited Investor Certification ---Financial CHOICE Act (House Discussion Draft) ---H.R. 79/S. 588: HALOS Act Sarbanes Oxley Section 404 (b) ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1645: Fostering Innovation Act Short Selling Transparency Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---Small Company Disclosure Simplification Act (House Discussion Draft)
Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension Capital Formation Investment Incentives ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---An Act to Modify Net Operating Loss Carryforwards (House Discussion Draft) Orphan Drug Act Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---New Production Tax Credit
Filing targets: Agriculture, Dept of (USDA), American Battle Monuments Commission, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR), White House Office
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2016 · fourth_quarter · Q4
21st Century Cures/ Senate Innovation for Healthier Americans ---H.R.34: 21st Century Cures Act ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---S. 524: Comprehensive Addiction and Recovery Act of 2016 ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---S. 3239/H.R. 5858: RACE for Children Act 340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 ---CREATES Act (House Energy & Commerce Committee Discussion Draft) Drug Evaluation and Review ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---CREATES Act (House Energy & Commerce Committee Discussion Draft) ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Independent Payment Advisory Board Orphan Drug Act Tax Credit Precision Medicine Initiative Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part B Physician-Administered Products ---Value-based Contracting and Communications TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---H.R. 3299: Strengthening Public Health Emergency Response Act ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---Supplemental Funding for Combating Zika ---Vaccine Injury Compensation Program ---Vaccine Safety
Biofuels (Non-Funding) ---Production Tax Credit Extension Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---H.R. 2179: PARTNER Act ---S. 537: COMPETE Act Inversions ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Treatment of Financial Interests as Stock or Indebtedness ---Section 385 Proposed Regulations Orphan Drug Act Tax Credit No sub-issues Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---New Production Tax Credit ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---S. 2271: The Renewable Chemical Production Tax Credit Act
Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act ---H.R. 2179: PARTNER Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 6427: Creating Financial Prosperity for Businesses and Investors Act ---PCAOB Audit Cost Increases Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4498/S. 978: HALOS Act Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Stock Exchange Tick Size XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, U.S. Trade Representative (USTR)
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2016 · third_quarter · Q3
Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---PCAOB Audit Cost Increases Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1965: Small Company Disclosure Simplification Act
Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biofuels (Non-Funding) ---Production Tax Credit Extension Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Inversions ---Treatment of Financial Interests as Stock or Indebtedness: Section 385 Proposed Regulations Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---S. 2271: The Renewable Chemical Production Tax Credit Act ---S. 1656/H.R. 2883: Master Limited Partnership Parity Act ---Expansion of Master Limited Partnerships to Renewable Chemicals Research & Development Tax Credit Reforms ---Extension ---H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities ---Permanency ---Refundable R&D Credit ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Orphan Drug Tax Credit
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of Technology Policy (OTP), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Vice President of the U.S.
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2016 · second_quarter · Q2
Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Inversions ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Orphan Drug Act Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---New Production Tax Credit ---S. 2271: The Renewable Chemical Production Tax Credit Act Research & Development Tax Credit Reforms ---Refundable R&D Credit
Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---Financial CHOICE Act (House Discussion Draft) Small Business Innovation Research (SBIR) Program Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 5311: The Corporate Governance Reform and Transparency Act of 2016 ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---H.R. 4498/S.978: HALOS Act ---H.R. 4852: Private Placement Improvement Act ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) Short Selling Transparency ---H.R.5485/S.3067: Financial Services and General Government Appropriations for FY 2017 XBRL Exemption for Small Public Companies ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act ---Financial CHOICE Act (House Discussion Draft) Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), SENATE, U.S. Trade Representative (USTR), White House Office
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2016 · first_quarter · Q1
Biosimilars --Coding --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Patent Certification --Brazil Biologics Regulations Funding for National Institutes of Health --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for Centers for Disease Control and Prevention Vaccine Programs --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 340B Drug Pricing Program --Implementation of Affordable Care Act --Program Implementation & Oversight --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Drug Importation --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Biodefense Research, Development and Procurement Issues (Nonfunding) Reimbursement for Innovative Products --Medicare Part B Physician-Administered Products --Medicare Part D Prescription Drug Program: ----CMS Proposed Rule on Protected Classes --Value-based Contracting and Communications Drug Evaluation and Review --Compassionate Use/Expanded Access --FDA Proposed Rule on Changes to Drug Labeling --Implementation of the FDA Safety and Innovation Act --Reauthorization of the Prescription Drug User Fee Act --Special Medical Use/Limited Population Drug ---- ADAPT Act (House Discussion Draft) Senate Innovation for Healthier Americans --Biomarkers and Regulatory Science Improvements --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives ----S. 195: PATH Act --Communication with Healthcare Professionals and Payors --Priority Review Voucher Programs Priority Review of Generic Drugs ----S. 2615: Increasing Competition in Pharmaceuticals Act Vaccines and Infectious Diseases - General Government Price Reporting --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Gene Editing Technologies --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act Drug Manufacturing, Quality & Distribution --Supply Chain Integrity and Traceability Affordable Care Act Implementation --Third Party Support of Patient Premiums and Cost-Sharing Obligations Combating Antibiotic-Resistant Bacteria (CARB) Initiative Vaccine Access/Financing --Adult Immunization (Senate Discussion Draft) --Implementation of Affordable Care Act --Senate Chronic Care Working Group Proposals --Vaccine Injury Compensation Program TransPacific Partnership --Data and Intellectual Property Protection for Pharmaceuticals --Reimbursement Transparency Orphan Drug Act Tax Credit UN Commission on Access to Medicines
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2015 · fourth_quarter · Q4
Biosimilars ---Biosimilar User Fee Act Implementation ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming Funding for the National Institutes of Health ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R.2029: Consolidated Appropriations Act for FY 2016 Vaccine Access/Financing ---Vaccine Injury Compensation Program 340B Drug Pricing Program ---Program Implementation & Oversight ---H.R.2029: Consolidated Appropriations Act for FY 2016 Medicaid Pricing and Rebates ---Implementation of Affordable Care Act ---Average Manufacturer Price Calculations Drug Importation ---H.R.2029: Consolidated Appropriations Act for FY 2016 ---Amendment to HR: 3762: The Restoring Americans Healthcare Freedom Reconciliation Act of 2015 Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2029: Consolidated Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues TransPacific Partnership ---Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Reimbursement Transparency Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based contracting and communications Drug Evaluation and Review ---Compassionate Use/Expanded Access ---FDA Proposed Rule on Changes to Drug Labeling ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---Special Medical Use/Limited Population Drug Orphan Drug Act Tax Credit Senate Innovation for Healthier Americans ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Generic Entry Incentives Vaccines and Infectious Diseases - General Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.2029: Consolidated Appropriations Act for FY 2016 Government Price Reporting ---H.R.2029: Consolidated Appropriations Act for FY 2016 Gene Editing Technologies ---H.R. 2029: Consolidated Appropriations Act for 2016 Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Precision Medicine Initiative
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2015 · third_quarter · Q3
Sarbanes Oxley Section 404 (b) --Exemption for Emerging Companies Capital Formation Investment Incentives --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act --H.R. 2179: PARTNER Act Expansion of Exemption under SEC Regulation A --H.R. 1839: Reforming Access for Investments in Startup Enterprises (RAISE) Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions --Fostering Innovation Act (House Discussion Draft) XBRL Exemption for Small Public Companies --H.R. 1965: Small Company Disclosure Simplification Act Capital Market Enhancements --SEC Office of Small Business Policy Responsibilities --H.R. 1525: Disclosure Modernization and Simplification Act --H.R. 1675: Encouraging Employee Ownership Act --H.R. 1723: Small Company Simple Registration Act --H.R. 2064: Improving Access to Capital for Emerging Growth Companies Act --H.R. 2357: Accelerating Access to Capital Act
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2015 · second_quarter · Q2
Patent Reform --H.R. 9: Innovation Act --Implementation of the America Invents Act of 2011 --S.1137: The PATENTS Act of 2015 Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership --Intellectual Property Issues Patenting of Biological Inventions --DNA Patenting and Licensing Trade Promotion Authority --HR 2146: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 --HR 1295: Trade Adjustment Assistance Act of 2015 Inter Partes Review --H.R. 2578: Commerce, Science, Justice and Related Agencies Appropriations Act of FY 2016 --Implementation of the American Invents Act of 2011 --S. 1137: The PATENTS Act of 2015 --S. 632: STRONG Patents Act of 2011 --H.R. 9: Innovation Act Colombia National Development Plan --Intellectual Property Issues IP Rights for Environmental Technologies --U.S. Government Position for U.N. Convention on Climate Change Negotiations
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2015 · first_quarter · 1A
Biofuels -Production Tax Credit Extension Research & Development Tax Credit Reforms -Permanency -Extension -S. 537: COMPETE Act -S. 341: Start-up Jobs and Innovation Act Capital Formation Investment Incentives -Reform of Capital Gains Rules -Reform of Net Operating Loss Rules -Reform of Passive Loss Rules -S. 341: Start-up Jobs and Innovation Act -S. 537: COMPETE Act -PARTNER Act (House Discussion Draft) Renewable Chemicals/Bio-based Products -New Production Tax Credit -Expansion of Master Limited Partnerships to Renewable Chemicals Tax Reform Orphan Drug Act Tax Credit
Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing -Adult Immunization (Senate Discussion Draft) -S.2694: Ensuring Access to Primary Care for Women and Children Act 340B Drug Pricing Program -Implementation of Affordable Care Act -Program Implementation & Oversight -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues (Non-funding) TransPacific Partnership -Data and Intellectual Property Protection for Pharmaceuticals -Regulatory Transparency Transatlantic Trade and Investment Partnership -Intellectual Property Issues -Regulatory Harmonization -Reimbursement Transparency Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --H.R. 1078: FDA Safety over Sequestration Act Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Medicare Physician Payment Sustainable Growth Rate Formula - HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Biomarkers and Regulatory Science Improvements -Communication with Healthcare Professionals -Expanded Access to Investigational Drugs -Expedited Pathways -FDA Hiring Flexibility -FDA Management and Financial Accountability -Innovation Incentives -Longitudinal Study of Chronic Diseases -Patient Access to Approved Drugs -Patient-Focused Drug Development -Use of Real-World Evidence -Vaccine and Anti-Microbial Resistance Product Development and Incentives -ADAPT Act (House Discussion Draft) -Sunshine Act Amendments -Coding -Coverage with Evidence Development Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Vaccines and Infectious Diseases - General Colombia National Development Plan -Regulatory Issues -Reimbursement Issues -Intellectual Property Issues
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2015 · first_quarter · Q1
Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing -Adult Immunization (Senate Discussion Draft) -S.2694: Ensuring Access to Primary Care for Women and Children Act 340B Drug Pricing Program -Implementation of Affordable Care Act -Program Implementation & Oversight -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues (Non-funding) TransPacific Partnership -Data and Intellectual Property Protection for Pharmaceuticals -Regulatory Transparency Transatlantic Trade and Investment Partnership -Intellectual Property Issues -Regulatory Harmonization -Reimbursement Transparency Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --H.R. 1078: FDA Safety over Sequestration Act Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Medicare Physician Payment Sustainable Growth Rate Formula - HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Biomarkers and Regulatory Science Improvements -Communication with Healthcare Professionals -Expanded Access to Investigational Drugs -Expedited Pathways -FDA Hiring Flexibility -FDA Management and Financial Accountability -Innovation Incentives -Longitudinal Study of Chronic Diseases -Patient Access to Approved Drugs -Patient-Focused Drug Development -Use of Real-World Evidence -Vaccine and Anti-Microbial Resistance Product Development and Incentives -ADAPT Act (House Discussion Draft) -Sunshine Act Amendments -Coding -Coverage with Evidence Development Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Vaccines and Infectious Diseases - General Colombia National Development Plan -Regulatory Issues -Reimbursement Issues -Intellectual Property Issues
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2014 · fourth_quarter · Q4
Sarbanes Oxley Section 404 (b) H.R. 1564/S. 1526: The Audit Integrity and Job Protection ActCapital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules S. 1658: The Start-up Jobs and Innovation Act S. 2260: EXPIRE Act of 2014 H.R. 4855, the PARTNER Act Expansion of Exemption under SEC Regulation A Proposed SEC Rule on Reg A+ H.R. 4565: Startup Capital Modernization Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions H.R. 2629: The Fostering Innovation Act XBRL Exemption for Small Public Companies H.R. 5405: The Promoting Job Creation and Reducing Small Business Burdens Act H.R. 4164: Small Company Disclosure Simplification Act Stock Exchange Tick Size H.R. 5405: Promoting Job Creation and Reducing Small Business Burdens Act H.R. 3448: The Small Cap Liquidity Reform Act Capital Market Enhancements H.R. 4568: Small Business Freedom to Grow Act H.R. 3623: Improving Access to Capital for Emerging Growth Companies Act H.R. 4697: To require the SEC to revise the definition of a WKSI to reduce the worldwide market value threshold under the definition H.R. 4569: Disclosure Modernization and Simplification Act H.R. 4571: To direct the SEC to revise its rules so as to increase the threshold amount for requiring issuers to provide certain disclosures relating to compensatory benefits plans
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2014 · third_quarter · Q3
Bonus Depreciation S. 2260: EXPIRE Act of 2014Tax Reform Orphan Drug Act Tax Credit Renewable Chemicals/Bio-based Products Bonus Depreciation for Renewable Chemical Facilities S. 2260: EXPIRE Act of 2014 Biofuels Accelerated Depreciation Extension Production Tax Credit Extension H.R. 3758: Second Generation Biofuel Extension Act of 2013 S. 2260: EXPIRE Act of 2014 Research & Development Tax Credit Reforms Extension Permanency H.R. 4438: American Research & Competitiveness Act of 2014 S. 2260: EXPIRE Act of 2014 S. 2715: The COMPETE Act S.193: The Start-up Innovation Credit Act Capital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules H.R. 4855: The PARTNER Act S. 1658: The Start-up Jobs and Innovation Act S. 2715: The COMPETE Act Controlled Foreign Corporation Look-Through Rule Extension S. 2260: EXPIRE Act of 2014 Inversions H.R.4870: Department of Defense Appropriations Act for FY 2015 H.R.5016: Financial Services and General Government Appropriations Act for FY 2015
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2014 · second_quarter · Q2
Tax Reform House Ways & Means Committee Discussion Draft (Rep. Camp)Orphan Drug Act Tax Credit Controlled Foreign Corporation Look-Through Rule Extension Renewable Chemicals/Bio-based Products Bonus Depreciation for Renewable Chemical Facilities Expansion of Master Limited Partnerships to Renewable Chemicals New Production Tax Credit for Renewable Chemicals S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act H.R. 1696/S. 795: Master Limited Partnerships Parity Act Biofuels Production Tax Credit Extension Accelerated Depreciation Extension H.R. 3758: Second Generation Biofuel Extension Act of 2013 Research & Development Tax Credit Reforms Extension Permanency H.R.3757: The Igniting American Research Act H.R. 4438: American Research & Competitiveness Act of 2014 H.R.119: To amend the Internal Revenue Code to make permanent the credit for increasing research activities The Start-up Innovation Credit Act (Senator Coons Discussion Draft) The COMPETE Act (Senator Carper Discussion Draft) Capital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules H.R. 4855: The PARTNER Act S. 1658: The Start-up Jobs and Innovation Act The COMPETE Act (Senator Carper Discussion Draft) House Ways & Means Committee Discussion Draft (Rep. Camp)
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2014 · first_quarter · Q1
Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014Biosimilars Naming Biosimilar User Fee Act Implementation Interchangeability and Pharmacy Substitution Colombia Biologics Regulations Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Vaccine Access/Financing Vaccine Injury Compensation Program Adult Immunization (Senate Discussion Draft) 340B Drug Pricing Program Program Implementation & Oversight Implementation of Affordable Care Act Department of Labor, HHS, Education and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Funding for FDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Reimbursement for Innovative Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes Medicare Part B Physician-Administered Products H.R. 1416: Cancer Patient Protection Act of 2013 National Center for Advancing Translational Science (NCATS) Program Implementation Sequestration of PDUFA Fees HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act H.R. 3547: Consolidated Appropriations Act for FY 2014 Drug Repurposing H.R. 4287/2150: Independent Innovator and Repurposing Act Transatlantic Trade and Investment Partnership Reimbursement Transparency Intellectual Property Issues Regulatory HarmonizationTransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Regulatory Transparency Drug Evaluation and Review Special Medical Use/Limited Population Drug H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Implementation of the FDA Safety and Innovation Act FDA Proposed Rule on Changes to Drug Labeling Orphan Drug Act Tax Credit Drug Manufacturing, Quality & Distribution Implementation of H.R. 3204: The Drug Quality and Security Act Sunshine Act Implementation Medicare Physician Payment Sustainable Growth Rate Formula HR 4302: Protecting Access to Medicare Act of 2014 S. 2110: Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014 S. 2000: SGR Repeal and Medicare Provider Payment Modernization Act of 2014 S. 2122: Responsible Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014 Clinical Trial Data Sharing and Disclosure EU Policies
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2013 · third_quarter · 3A
Vaccine Access/Financing Adult Immunization (Senate Discussion Draft)Biosimilars Colombia Biologics Regulations Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Interchangeability and Pharmacy Substitution Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act S.1284: Department of Labor, HHS, Education, and Related Agencies Appropriations Act of 2014 Expanded Access to Experimental Products FDA Rules Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Independent Payment Advisory Board S.351/H.R. 351: Protecting Seniors' Access to Medicare Act of 2013 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Harmonization Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program H.R. 1416: Cancer Patient Protection Act of 2013 National Center for Advancing Translational Science (NCATS) Funding Program Implementation Asia Pacific Economic Cooperation Forum Biologics RegulationTransatlantic Trade and Investment Partnership Intellectual Property Issues Regulatory Harmonization Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and related agencies Appropriations Act FY 2014 H.R. 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act H.J. Res 59: Continuing Appropriations Act for FY 2014 Drug Safety and Review PDUFA V Implementation FDA Safety and Innovation Act Implementation Supply Chain Integrity Special Medical Use/Limited Population Drugs Pharmacy Compounding S. 957: Drug Supply Chain Security Act, S.959: Pharmaceutical Compounding Quality Act H.R. 1919: The Safeguarding America Pharmaceuticals Act Orphan Drug Act Issues Tax Credit Clinical Trial Data Sharing
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2013 · fourth_quarter · 4A
Biofuels Production Tax Credit Extension Accelerated Depreciation Extension H.R. 3758: Second Generation Biofuel Extension Act of 2013Renewable Chemicals/Bio-based Products Investment Tax Credit for Renewable Chemicals and Bio-based Products New Production Tax Credit for Renewable Chemicals Expansion of Master Limited Partnerships to Renewable Chemicals H.R. 1696/S. 795: Master Limited Partnerships Parity Act S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act Research & Development Tax Credit Reforms Extension Permanency H.R.119: To amend the Internal Revenue Code to make permanent the credit for increasing research activities H.R.3757: The Igniting American Research Act The Innovative Research and Competitiveness Act (Senator Carper Discussion Draft), The Start-up Innovation Credit Act (Senator Coons Discussion Draft) Capital Formation Investment Incentives Reform of Passive Loss Rules Reform of Net Operating Loss Rules Reform of Capital Gains Rules S. 1658: The Start-up Jobs and Innovation Act Tax Reform Orphan Drug Act Tax Credit
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2013 · fourth_quarter · Q4
Sarbanes Oxley Section 404 (b) Mandatory Audit Firm Rotation H.R. 1564/S. 1526: The Audit Integrity and Job Protection ActCapital Formation Investment Incentives Reform of Passive Loss Rules Reform of Net Operating Loss Rules Reform of Capital Gains Rules S. 1658: The Start-up Jobs and Innovation Act Reform of SEC Regulation D Implementation of Jumpstart Our Business Start-ups (JOBS) Act Expansion of Exemption under SEC Regulation A H.R. 701: To amend a provision of the Securities Act of 1933 directing the Securities and Exchange Commission to add a particular class of securities to those exempted under such Act to provide a deadline for such action Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions H.R. 2629: The Fostering Innovation Act XBRL Exemption for Small Public Companies Small Company Disclosure Simplification Act (Reps. Hurt and Sewell Discussion Draft) Stock Exchange Tick Size H.R. 1952: The Spread Pricing Liquidity Act H.R. 3488: The Small Cap Liquidity Reform Act
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2013 · third_quarter · Q3
Vaccine Access/Financing Adult Immunization (Senate Discussion Draft)Biosimilars Colombia Biologics Regulations Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Interchangeability and Pharmacy Substitution Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act S.1284: Department of Labor, HHS, Education, and Related Agencies Appropriations Act of 2014 Expanded Access to Experimental Products FDA Rules Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Independent Payment Advisory Board S.351/H.R. 351: Protecting Seniors' Access to Medicare Act of 2013 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Harmonization Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program H.R. 1416: Cancer Patient Protection Act of 2013 National Center for Advancing Translational Science (NCATS) Funding Program Implementation Asia Pacific Economic Cooperation Forum Biologics RegulationTransatlantic Trade and Investment Partnership Intellectual Property Issues Regulatory Harmonization Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and related agencies Appropriations Act FY 2014 H.R. 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act H.J. Res 59: Continuing Appropriations Act for FY 2014 Drug Safety and Review PDUFA V Implementation FDA Safety and Innovation Act Implementation Supply Chain Integrity Special Medical Use/Limited Population Drugs Pharmacy Compounding S. 957: Drug Supply Chain Security Act, S.959: Pharmaceutical Compounding Quality Act H.R. 1919: The Safeguarding America Pharmaceuticals Act Orphan Drug Act Issues Tax Credit Clinical Trial Data Sharing
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2013 · second_quarter · Q2
Biofuels Production Tax Credit ExtensionTax Reform Renewable Chemicals/Bio-based Products Expansion of Advanced Manufacturing Investment Tax Credit to Renewable Chemicals and Bio-based Products Expansion of Master Limited Partnerships to Renewable Chemicals S. 1267: Qualifying Renewable Chemical Production Tax Credit Act of 2013 H.R. 1696/S. 795: Master Limited Partnerships Parity Act Vaccine Access/Financing Tax on Seasonal Influenza Vaccine H.R. 425/S.391: A Bill To Amend the Internal Revenue Code of 1986 to Include Vaccines Against Seasonal Influenza Within the Definition of Taxable Vaccines Capital Formation Investment Incentives H.R. 6599/S.3595: High Technology Small Business Research Incentives Act Reform of Passive Loss Rules Reform of Net Operating Loss Rules Reform of Capital Gains Rules Research & Development Tax Credit Extension Orphan Drug Tax Credit
Reform of SEC Regulation D Implementation of H.R. 3606: Jumpstart Our Business Start-ups (JOBS) ActCapital Formation Investment Incentives H.R. 6599/S.3595: High Technology Small Business Research Incentives Act Reform of Passive Loss Rules Reform of Net Operating Loss Rules Reform of Capital Gains Rules Expansion of Exemption Under SEC Regulation A H.R. 701: To amend a provision of the Securities Act of 1933 directing the Securities and Exchange Commission to add a particular class of securities to those exempted under such Act to provide a deadline for such action. Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions Fostering Innovation Act (Rep. Fitzpatrick Discussion Draft) Market Structure Reform for Small Companies XBRL Exemption for Small Public Companies Sarbanes Oxley Section 404 (b) Mandatory Audit Firm Rotation H.R. 1564: The Audit Integrity and Job Protection Act Stock Exchange Tick Size H.R. 1952: The Spread Pricing Liquidity Act Tick Size Flexibility Act (Rep. Duffy Discussion Draft)
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2013 · first_quarter · Q1
Small Business Innovation Research (SBIR) Program Implementation of Final RulemakingResearch & Development Tax Credit Extension Startup Innovation Credit (Senator Coons Discussion Draft) Innovative Research and Competitiveness Act (Senator Carper Discussion Draft)
Biofuels Production Tax Credit Extension Accelerated Depreciation ExtensionResearch & Development Tax Credit Extension Startup Innovation Credit (Senator Coons Discussion Draft) Innovative Research and Competitiveness Act (Senator Carper Discussion Draft) Capital Formation Investment Incentives High Technology Small Business Research Incentives Act (Discussion Draft) Vaccine Access/Financing Tax for Seasonal Influenza Funding H.R. 425/S.391: A bill to amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines Tax Reform Renewable Chemicals/Bio-based Products New Production Tax Credit for Renewable Chemicals Expansion of Advanced Manufacturing Investment Tax Credit to Renewable Chemicals and Bio-Based Products Expansion of Master Limited Partnerships to Renewable Chemicals
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2012 · fourth_quarter · Q4
Small Business Innovation Research (SBIR) Program Rulemaking Market Structure Reform for Small Companies Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions H.R. 6161: Fostering Innovation Act of 2012 Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Capital Formation Investment Incentives H.R. 6599/S.3595: High Technology Small Business Research Incentives Act of 2012
Bio-based Products Tax Credit H.R. 4953/S.3491: Qualifying Renewable Chemical Production Tax Credit Act of 2012 Vaccine Access/Financing Tax for Seasonal Influenza Funding H.R. 6687/S.3716: A Bill to Amend the Internal Revenue Code of 1986 to Include Vaccines against Seasonal Influenza within the Definition of Taxable Vaccines Tax Reform Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Capital Formation Investment Incentives H.R. 6599/S.3595: High Technology Small Business Research Incentives Act of 2012 Research & Development Tax Credit Extension Innovative Research and Competitiveness Act (Senator Carper Discussion Draft) Startup Innovation Credit Act (Senator Coons Discussion Draft) American Taxpayer Relief Act (Discussion Draft) S.3521: Family and Business Tax Cut Certainty Act of 2012 Biofuels Production Tax Credit Modification for Algae-based Biofuels Production Tax Credit Extension Investment Tax Credit Options S. 3521: Family and Business Tax Cut Certainty Act of 2012 American Taxpayer Relief Act (Discussion Draft) Renewable Chemicals H.R. 4953/S.3491: Qualifying Renewable Chemical Production Tax Credit Act of 2012
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2012 · third_quarter · 3A
Pharmaceutical Industry Annual Fee Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Treasury and IRS Regulations Implementing the Law Biosimilars Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Colombia Biologics Regulations Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translations Science (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Vaccine Access/Financing Tax for Seasonal Influenza Funding Taxable Vaccines Act (Discussion Draft) 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Average Manufacturer Price Calculations Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Access to External Experts Conflicts of Interest Drug Shortages E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discussion Draft) Expedited Approval Pathways FDA Mission Regulatory Reforms for Innovative Products Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development, and Procurement HHS Countermeasures Review S.1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Reimbursement for Innovative Products Medicare Part D Prescription Drug Program Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2012 · third_quarter · Q3
Research & Development Tax Credit Extension Innovative Research and Competitiveness Act (Senator Carper Discussion Draft) Startup Innovation Credit (Senator Coons Discussion Draft) Small Business Innovation Research (SBIR) Program Rulemaking
Vaccine Access/Financing Tax for Seasonal Influenza Funding Taxable Vaccines Act (Discussion Draft) Tax Reform Bio-based Products Tax Credit S. 3491/H.R. 4953: Qualifying Renewable Chemical Production Tax Credit Act of 2012 Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Extension Pharmaceutical Industry Annual Fee Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Treasury and IRS Regulations Implementing the Law Biofuels Biofuels Production Tax Credit Modification for Algae-based Biofuels Biofuels Production Tax Credit Extension S. 3521: Family and Business Tax Cut Certainty Act of 2012 Research & Development Tax Credit Extension Innovative Research and Competitiveness Act (Senator Carper Discussion Draft) Startup Innovation Credit (Senator Coons Discussion Draft) Capital Formation Investment Incentives H.R. 6599/S.3595: High Technology Small Business Research Incentives Act of 2012 Renewable Chemicals S. 3491/H.R. 4953: Qualifying Renewable Chemical Production Tax Credit Act of 2012 S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S. 1764: Make It in America Tax Credit Act of 2011
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2012 · second_quarter · Q2
Vaccine Access/Financing Tax for Seasonal Influenza Funding Bio-based Products Tax Credit Biofuels Biofuels Production Tax Credit Extension Biofuels Production Tax Credit Modification for Algae-based Biofuels Renewable Chemicals New Production Tax Credit/Revisions to Existing Tax Credits S. 1764: Make It in America Tax Credit Act of 2011 S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 4953: Qualifying Renewable Chemical Production Tax Credit Act of 2012 Therapeutic Discovery Project Tax Credit Extension S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Capital Formation Investment Incentives Research & Development Tax Credit Extension
Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Reimbursement Issues Comparative Effectiveness Research Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translation Science (NCATS) S. 3295: Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Vaccine Access/Financing Tax for Seasonal Influenza Funding Adult Immunization Policies Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement (Non-Funding Issues) S. 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Therapeutic Discovery Project Tax Credit Extension S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2012 · first_quarter · Q1
Expansion of Exemption under SEC Regulation A H.R. 3606: Jumpstart Our Business Start-ups (JOBS) Act Sarbanes Oxley Section 404 (b) H.R. 3606: Jumpstart Our Business Start-ups (JOBS) Act S.1933: Reopening American Capital Markets to Emerging Growth Companies Act of 2011 H.R. 3213: Small Company Job Growth and Regulatory Relief Act of 2011 Small Business Early-Stage Investment H.R. 3606: Jumpstart Our Business Start-ups (JOBS) Act Therapeutic Discovery Project Tax Credit Extension Capital Formation Investment Incentives Reform of SEC Regulation D H.R. 3606: Jumpstart Our Business Start-ups (JOBS) Act S. 1831/H.R. 2940: Access to Capital for Job Creators Act of 2011 Shareholder Reporting Threshold S. 1824/H.R. 2167: Private Company Flexibility and Growth Act of 2011
Research & Development Tax Credit Extension H.R. 3606: Jumpstart Our Business Start-ups (JOBS) Act
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2011 · fourth_quarter · Q4
TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations for FY 2012 Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2012 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Vaccine Access/Financing Adult Immunization Policies Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act 340B Drug Pricing Program Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act HRSA Implementation of Program Changes Federal Supply Schedule Access During Emergencies Expanded Access to Experimental Products Medicaid Rebates Dual Eligibles S 365: Budget Control Act of 2011 Drug Importation H.R. 2112: Consolidated and Further Continuing Appropriations Act of 2012 Diagnostics and Personalized Medicine Regulation and Oversight Therapeutic Discovery Project Tax Credit Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review FDA Globalization Act (Discussion Draft) Prescription Drug User Fee Act (PDUFA) Reauthorization Regulatory Reforms for Innovative Products TREAT Act (Senate Discussion Draft) E-Pedigree and Anti-Counterfeiting Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 2112: Consolidated and Further Continuing Appropriations Act of 2012 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2012 Cures Acceleration Network S. R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2012 National Center for Advancing Translational Sciences S.R. 1599: Departments of Labor, HHS, Education, and Related Agencies Appropriations for FY 2012 Biodefense Research, Development and Procurement HHS Countermeasures Review S. 1855: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 Drug Shortages S. 296: Preserving Access to Life-Savings Medicines Act of 2011 H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 Reimbursement for Innovative Products Part B Physician-Administered Products Medicare Part D Prescription Drug Program International Biosecurity Policies Biologics and Toxins Weapons Convention
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2011 · third_quarter · Q3
Bio-based Products Tax Credit Therapeutic Discovery Project Tax Credit Extension Biofuels Investment Tax Credit Options Biofuels Production Tax Credit Modification for Algae-based Biofuels Biofuels Production Tax Credit Extension Capital Formation Investment Incentives Expansion of Eligibility under SEC Regulation A H.R. 1070: The Small Company Capital Formation Act
Capital Formation Investment Incentives Sarbanes Oxley Section 404 (b) Exemption Small Company Job Growth and Regulatory Relief Act of 2011 (Discussion Draft) Small Business Innovation and Research (SBIR) Program Reauthorization HR 1425: Creating Jobs through Small Business Innovation Act of 2011 S.493: SBIR/STTR Reauthorization Act of 2011 Small Business Early-Stage Investment Therapeutic Discovery Project Tax Credit Extension Expansion of Eligibility under SEC Regulation A H.R. 1070: The Small Company Capital Formation Act
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2011 · second_quarter · Q2
Bio-based Products Tax Credit Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation Therapeutic Discovery Project Tax Credit Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Extension Biofuels Biofuels Production Tax Credit Modification for Algae-based Biofuels Biofuels Production Tax Credit Extension Investment Tax Credit Options Research & Development Tax Credit Extension H.R. 942: American Research and Competitiveness Act of 2011 Capital Formation Investment Incentives Renewable Chemicals New Production Tax Credit/Revisions to Existing Tax Credits
Capital Formation Investment Incentives Sarbanes Oxley Section 404 (b) Exemption Small Business Innovation and Research (SBIR) Program Reauthorization S.493: SBIR/STTR Reauthorization Act of 2011 HR 1425: Creating Jobs Through Small Business Innovation Act of 2011 Therapeutic Discovery Project Tax Credit Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Extension
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2011 · first_quarter · Q1
Bio-based Products Tax Credit Therapeutic Discovery Project Tax Credit Extension Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Biofuels Biofuels Production Tax Credit Modification for Algae-based Biofuels Biofuels Production Tax Credit Extension Investment Tax Credit Options Research & Development Tax Credit Extension H.R. 942: American Research and Competitiveness Act of 2011 Pharmaceutical Industry Annual Fee Treasury and IRS Regulations Implementing the Law
Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Comparative Effectiveness Program Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health H.R. 1: Full-Year Continuing Appropriations Act for FY 2011 Vaccine Access/Financing Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Diagnostics and Personalized Medicine Regulation and Oversight Therapeutic Discovery Project Tax Credit Extension Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Safety and Review Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative Funding for FDA H.J. RES. 48: 6th Continuing Resolution for FY 2011 Independent Payment Advisory Board Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R. 1: Full-Year Continuing Appropriations Act for FY 2011 H.J. RES. 48: 6th Continuing Resolution for FY 2011 Pharmaceutical Industry Annual Fee Treasury and IRS Regulations Implementing the Law Biodefense Research, Development and Procurement HHS Countermeasures Review Drug Shortages S. 296: Preserving Access to Life-Savings Medicines Act of 2011
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2010 · fourth_quarter · Q4
Pharmaceutical Industry Annual Fee Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Treasury and IRS Regulations Implementing the Law Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Comparative Effectiveness Program Initiatives Nomination of Board Members for the Patient-Centered Outcomes Research Institute Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Vaccine Access/Financing Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Expansion of 340B Drug Pricing Program Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011 H.R. 4994: Taxpayer Assistance Act of 2010 H.R. 4213: American Jobs and Closing Tax Loopholes Act of 2010 Funding for Centers for Disease Control and Prevention Vaccine Programs S.3686: Departs of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Strategic National Stockpile S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011 S.3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Drug Importation S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 S.3607: Department of Homeland Security Appropriations Act for FY 2011 S.3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Funding for National Institutes of Health H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011 S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Cures Acceleration Network Funding: S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011 Funding for Pandemic Influenza Preparedness S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011 Funding for Biomedical Advanced Research & Development Authority (BARDA) S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011 Funding for Bioterrorism and Emergency Preparedness S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 3082/HJ RES. 105/HJ RES. 101/S. Amendment to H. 3081: Continuing Appropriations Acts for FY 2011 Biodefense Research, Development and Procurement HHS Countermeasures Review Funding: H.R. 3082: 4th Continuing Appropriations Act for FY 2011 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 Stem Cell Research Federal Funding of Embryonic Stem Cell Research Average Manufacturer Price Calculations H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 H.R. 4213: American Jobs and Closing Tax Loopholes Act of 2010 Diagnostics and Personalized Medicine Regulation and Oversight Draft Legislation Therapeutic Discovery Project Tax Credit Extension Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Safety and Review FDA Globalization Act (Discussion Draft) Prescription Drug User Fee Act (PDUFA) Reauthorization Generic Drug Patent Settlements S. 3677: Financial Services and General Government Appropriations Act for FY 2011 H.R. 3082: 4th Continuing Appropriations Act for FY 2011 S. 4322: Preserve Access to Affordable Generics Act Independent Payment Advisory Board Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act
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2010 · third_quarter · Q3
Pharmaceutical Industry Annual Fee Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Treasury and IRS Regulations Implementing the Law Research & Development Tax Credit Extension H.R. 4213: American Jobs & Closing Tax Loopholes Act Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation Senate Substitute to H.R. 5297: Small Business Lending Fund Act of 2010 Biofuels Production Tax Credit Modification for Algae-based Biofuels H.R. 4168: Algae-based Renewable Fuel Promotion Act of 2009 H.R. 5142 Grow Renewable Energy Economy Now-Jumpstart Other Biofuels Act of 2010 S. 1250: Algae-based Renewable Fuel Promotion Act of 2009 Therapeutic Discovery Project Tax Credit Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Biorefineries Modification of the Advanced Energy Products Tax Credit Next Generation Incentive Tax Credit H.R. 5142: Grow Renewable Energy Economy Now-Jumpstart Other Biofuels Act of 2010 Biofuels Production Tax Credit Extension H.R. 5142: Grow Renewable Energy Economy Now-Jumpstart Other Biofuels Act of 2010 Bio-based Products Tax Credit
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2010 · second_quarter · Q2
Small Business Innovation and Research (SBIR) Program Reauthorization H.R. 2965/S.1233: Enhancing Small Business Research and Innovation Act of 2009 Modifications to Internal Revenue Code Section 1202 for Qualified Small Business Stock Incentive H.R. 4173: Wall Street Reform and Consumer Protection Act of 2009 Sarbanes Oxley Section 404 (b) Exemption H.R. 4173: Wall Street Reform and Consumer Protection Act of 2009 Senate Financial Regulatory Reform Discussion Draft Therapeutic Discovery Project Tax Credit Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Small Business Early-Stage Investment H.R. 5297: Small Business Lending Fund Act of 2010
Alliance for Healthcare Competitiveness Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Comparative Effectiveness Program Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Nomination of Board Members for the Patient-Centered Outcomes Research Institute Cures Acceleration Network Funding Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Importation Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Department of Homeland Security Appropriations Act for FY 2011 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Expansion of 340B Drug Pricing Program Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 4213: American Jobs and Closing Tax Loopholes Act of 2010 Funding for Biomedical Advanced Research & Development Authority (BARDA) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 Funding for National Institutes of Health Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 Funding for Strategic National Stockpile Department of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Funding for the Food and Drug Administration Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Medicaid Rebates Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Medicare Prescription Drug Coverage Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Stem Cell Research Therapeutic Discovery Project Tax Credit Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Average Manufacturer Price Calculations H.R. 4213: American Jobs and Closing Tax Loopholes Act of 2010 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 Biodefense Research, Development and Procurement S.1649/H.R 5498: Weapons of Mass Destruction Prevention and Preparedness Act Human Drug Review Program Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative Diagnostics and Personalized Medicine Regulation and Oversight Draft Legislation Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Expanded Access to Experimental Products FDA Rules Vaccine Access/Financing Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act: GAO Study
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2010 · first_quarter · Q1
Therapeutic Discovery Project Tax Credit S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Therapeutic Discovery Project Tax Credit Cont... H.R. 4872: Health Care and Education Reconciliation Act of 2010 Bio-based Products Tax Credits Pharmaceutical Fee S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act Research and Development Tax Credit Extension H.R. 4213: Tax Extenders Act of 2009 Biofuels Production Tax Credit Modification for Algae-based Biofuels S.1250: Algae-based Renewable Fuel Promotion Act of 2009 H.R. 4168: Algae-based Renewable Fuel Promotion Act of 2009 Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation Modification to Internal Revenue Code Section 1202 for Qualified Small Business Stock Incentive Biofuels Production Tax Credit Extension Biorefineries Next Generation Tax Credits Modifications to the Advanced Energy Products Tax Credits
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2009 · fourth_quarter · Q4
Healthcare Reform Comparative Effectiveness Research Program Initiatives In Vitro Diagnostics Regulatory Oversight Vaccine Access/Financing Health Care Reform Cont... Follow-on Biologics Reporting of Physician Payments Expansion of 340B Drug Pricing Program Generic Fill Incentives Therapeutic Discovery Project Tax Credit Pharmaceutical Excise Tax Medicaid Rebates Dual Eligibles H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act H.R. 3200: America's Affordable Health Choices Act of 2009 S. 1679: Affordable Health Choices Act of 2009 S.1796: America's Healthy Future Act of 2009 Drug Safety and Review H.R. 759: FDA Globalization Act of 2009 S. 882: Drugs and Device Accountability Act of 2009 H.R. 2749: Food Safety Enhancement Act of 2009 Critical Path FDA Regulatory Transparency Drug Importation S.525: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 2892: Department of Homeland Security Appropriations Act for FY 2010 S.1232: Pharmaceutical Market Access Act of 2009 S.80: Pharmaceutical Market Access Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for the Food and Drug Administration H.R. 2997?S.1406: Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act for FY 2010 Stem Cell Research Medicaid Rebates S.1796: America's Healthy Future Act of 2009 S.1679: Affordable Health Choices Act of 2009 H.R. 3200: America's Affordable Health Choices Act H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Dual Eligibles Generic Fill Incentives H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Funding for Biomedical Advanced Research & Development Authority (BARDA) H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 In Vitro Diagnostics Regulatory Oversight H.R. 3200: America's Affordable Health Choices Act S.1679: Affordable Health Choices Act of 2009 S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Comparative Effectiveness Program Initiatives S.1213: Patient-Centered Outcomes Research Act of 2009 H.R. 2502: Comparative Effectiveness Research Act of 2009 H.R. 2824: Doctor-Patient Relationship and Research Protection Act S.1796: America's Healthy Future Act of 2009 S.1679: Affordable Health Choices Act of 2009 H.R. 3200: America's Affordable Health Choices Act H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Funding for National Institutes of Health H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 Funding for Bioterrorism and Emergency Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 Funding for Pandemic Influenza Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 H.R. 3288: Consolidated Appropriations Act for FY 2010 Reporting of Physician Payments S. 310: Physician Payments Sunshine Act of 2009 H.R. 3200: America's Affordable Health Choices Act H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Vaccine Access/Financing S.1796:America's Healthy Future Act of 2009 S.1679: America's Affordable Health Choices Act of 2009 H.R. 3200: America's Affordable Health Choices Act H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act S. 2868: Federal Supply Scheduels Usage Act of 2009 S.1649: Weapons of Mass Destruction Preparedness Act of 2009 Expansion of 340B Drug Pricing Program S.1796:America's Healthy Future Act of 2009 S.1679: Affordable Health Choices Act of 2009 H.R. 3200: America's Affordable Health Choices Act H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Federal Supply Schedule Access S.2868: Federal Supply Schedules Usage Act of 2009 Follow-on Biologics H.R. 1427: Promoting Innovation and Access to Life-Saving Medicines Act H.R. 1548: Pathway for Biosimilars Act of 2009 S. 726: Promoting Innovation and Access to Life-Saving Medicine Act H.R. 3200: America's Affordable Health Choices Act S.1679: Affordable Health Choices Act of 2009 S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Reimbursement Issues
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2009 · third_quarter · Q3
Healthcare Reform H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 Health Care Reform Cont... Comparative Effectiveness Research Program Initiatives Hospital Acquired Infections Policy In Vitro Diagnostics Regulatory Oversight Vaccine Access/Financing Follow-on Biologics Reporting of Physician Payments Expansion of 340B Drug Pricing Program Medicaid Rebates S.1213: Patient-Centered Outcomes Research Act of 2009 H.R. 2502: Comparative Effectiveness and Research Protection Act H.R. 2824 Doctor-Patient Relationship and Research Protection Act Pharmaceutical Excise Tax Funding for the Food and Drug Administration H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 Stem Cell Research Medicaid Rebates H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 Follow-on Biologics H.R. 1427: Promoting Innovation and Access to Life-Saving Medicines Act H.R. 1548: Pathway for Biosimilars Act of 2009 S. 726: Promoting Innovation and Access to Life-Saving Medicine Act FTC Report on Follow-on Biologics Marketplace H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 House Judiciary Committee Hearing on Patent Issues Drug Safety and Review E-Pedigree and Anti-counterfeiting H.R. 2749: Food Safety Enhancement Act of 2009 H.R. 759: FDA Globalization Act of 2009 S. 882: Drugs and Device Accountability Act of 2009 The Food and Drug Administration Amendments Act of 2007 Implementation Risk Evaluation Mitigation Strategies Adverse Event Monitoring/Sentinel Network Advisory Committee System Critical Path FDA Regulatory Transparency Measurement Standards for Review and Approval of Biologics House Science Committee Hearing Funding for Biomedical Advanced Research & Development Authority (BARDA) H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 In Vitro Diagnostics Regulatory Oversight H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 Comparative Effectiveness Program Initiatives Implementation of H.R. 1. and S.Amdt. 570: American Recovery and Reinvestment Act of 2009 H.R. 2502: Comparative Effectiveness Research Act of 2009 H.R. 2824: Doctor-Patient Relationship and Research Protection Act S.1213: Patient-Centered Outcomes Research Act of 2009 H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 Funding for National Institutes of Health H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for Bioterrorism and Emergency Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Funding for Pandemic Influenza Preparedness H.R. 3293: Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2010 Reporting of Physician Payments S. 301: Physician Payments Sunshine Act of 2009 H.R. 3200: America's Affordable Health Choices Act Senate Finance Committee's America's Healthy Future Act of 2009 Drug Importation S.525: Pharmaceutical Market Access and Drug Safety Act of 2009 H.R. 2997/S.1406: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2010 H.R. 3293: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2010 Department of Homeland Security Appropriations Act for FY 2010 S.1232: Pharmaceutical Market Access Act of 2009 H.R. 1298: Pharmaceutical Market Access and Drug Safety Act of 2009 S.80: Pharmaceutical Market Access Act of 2009 Vaccine Access/Financing H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 FDA Regulatory Processes for First-Time Filers Expansion of 340B Drug Pricing Program H.R. 3200: America's Affordable Health Choices Act S.1679: America's Affordable Health Choices Act of 2009 Senate Finance Committee's America's Healthy Future Act of 2009 S.1239: 340B Program Improvement and Integrity Act of 2009 Outpatient Prospective Payment System CY2010 Proposed Regulations Payment Methodology for Separately Billable Drugs and Biologics
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2009 · second_quarter · Q2
Therapeutic Development Investment Tax Credit Senate Finance Committee Healthcare Reform Discussion Draft Administration's International Tax Reform Proposals Bio-based Products Tax Credits
Filing targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, Small Business Administration (SBA), State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2009 · first_quarter · Q1
Accelerating of NOLs in Lieu of Other Tax Benefits (Refundable Tax Credit/Grant Proposals) H.R. 1. and S. Amdt. 570: American Recovery & Reinvestment Act of 2009
Accelerating of NOLs in Lieu of Other Tax Benefits (Refundable Tax Credits/Grant Proposals) H.R. 1. and S. Amdt. 570: American Recovery & Reinvestment Act of 2009 Investment Tax Credit for Therapeutic Development
Small Business Innovation and Research (SBIR) Program Reauthorization SBA Grant Proposal for High-Growth Companies Accelerating of NOLs in Lieu of Other Tax Benefits (Refundable Tax Credits/Grant Proposals) H.R. 1. and S. Amdt. 570: American Recovery & Reinvestment Act of 2009
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2008 · second_quarter · 2A
Small Business Innovation and Research Program (SBIR) H.R. 5819: SBIR Reauthorization Act Sarbanes-Oxley Reform Section 404 SEC and PCAOB Guidance on Auditing Standard (AS-5) S.3260: Financial Services and General Government Appropriations Act for FY 2009 FDA Regulatory Processes for First-Time Filers Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation H.R. 3221 Net Operating Loss Limitation Reform/Internal Revenue Code Section 382 H.R. 3264: American Sciences Competitiveness Act
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Funding for the Food and Drug Administration (Human Drug, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 (Cont...) Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Service (APHIS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels (Rural Development)) Drug Importation Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research & Development Authority (BARDA) Drug Importation Energy and Water Development and Related Agencies Appropriations Act for FY 2009 Funding for Biofuels S.3260: Financial Services and General Government Appropriations Act for FY 2009 Sarbanes Oxley - Section 404 Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009 Funding for Technology Innovation Program (TIP) Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2009 Funding for Biotechnology Research and Development Programs at the Agency for International Development Department of the Interior, Environment, and Related Agencies Appropriations for FY 2009 Funding for the Environmental Protection Agency FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for the Food and Drug Administration (Human Drug, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) Funding for Biomedical Advanced Research & Development Authority (BARDA) Funding for USDA/APHIS Funding for Biorefinery Construction, Research & Development Department of Homeland Security Appropriations Act for FY 2009 Drug Importation
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2008 · fourth_quarter · Q4
Small Business Innovation and Research Program (SBIR) H.R. 5819: SBIR Reauthorization Act S.3362 Sarbanes-Oxley Reform Section 404 H.R. 7323/S.3260:Financial Services and General Government Appropriations Act for FY 2009 FDA Regulatory Processes for First-Time Filers Modification/Extension of R&D/AMT Tax Credits in Lieu of Bonus Depreciation H.R. 7327: Worker, Retiree, and Employer Recovery Act of 2008 S.1: American Recovery & Reinvestment Act of 2009 Net Operating Losses Monetization Tax Proposal S.1: American Recovery & Reinvestment Act of 2009
Sarbanes-Oxley Reform Section 404 H.R. 7323/S.3260: Financial Services and General Government Appropriations Act for FY 2009 Modification/Extension of R&D/AMT Tax Credits in Lieu of Bonus Depreciation H.R. 7327: Worker, Retiree, and Employer Recovery Act of 2008 S.1: American Recovery & Reinvestment Act of 2009
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2008 · third_quarter · Q3
Small Business Innovation and Research Program (SBIR) H.R. 5819: SBIR Reauthorization Act S.3362 SBA Proposed Rule on SBIR Award Caps Sarbanes-Oxley Reform Section 404 S.3260: Financial Services and General Government Appropriations Act for FY 2009 FDA Regulatory Processes for First-Time Filers Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation H.R. 3221
Stem Cell Research Small Business Innovation and Research Program (SBIR) H.R. 5819: SBIR Reauthorization Act S.3362 SBA Proposed Rule on SBIR Award Caps R&D Tax Credit H.R. 6049 H.R. 1424 Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation H.R. 3221 Technology Innovation Program (TIP) Proposed Rules by National Institutes for Standards & Technology Funding S:3282: Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2008 · second_quarter · Q2
Small Business Innovation and Research Program (SBIR) H.R. 5819: SBIR Reauthorization Act Sarbanes-Oxley Reform Section 404 SEC and PCAOB Guidance on Auditing Standard (AS-5) S.3260: Financial Services and General Government Appropriations Act for FY 2009 FDA Regulatory Processes for First-Time Filers Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation H.R. 3221 Net Operating Loss Limitation Reform/Internal Revenue Code Section 382 H.R. 3264: American Sciences Competitiveness Act
Stem Cell Research Small Business Innovation and Research Program (SBIR) H.R. 5819: SBIR Reauthorization Act R&D Tax Credit H.R. 6049 Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation H.R. 3221 Technology Transfer Policies Technology Innovation Program (TIP) Proposed Rules by National Institutes for Standards & Technology Funding --Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2008 · first_quarter · 1A
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY2009 Funding for the Food and Drug Administration (Human Drug Review, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) Cont.... Funding for the Department of Agriculture (Biotechnology Regulatory Services (APHIS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service) Agriculture Research Service, Biofuels (Rural Development) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research & Development Authority (BARDA) Energy and Water Development and Related Agencies Appropriations Act for FY 2009 Funding for Biofuels Financial Services and General Government Appropriations Act for FY 2009 Sarbanes Oxley Reform Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009 Funding for Technology Innovation Program (TIP) Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2009 Funding for Biotechnology Research and Development Programs at the Agency for International Development Department of the Interior, Environment, and Related Agencies Appropriations for FY 2009 Funding for the Environmental Protection Agency
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2008 · first_quarter · 1A
Biofuels Tax Credit Implementation of the Renewable Fuels, Consumer Protection and Energy Efficiency Act of 2007 H.R. 2419 Bio-based Products Tax Credits R&D Tax Credit Extension of Expired R&D Tax Credit Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation S.12 H.R. 5140
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY2009 Funding for the Food and Drug Administration (Human Drug Review, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) Cont.... Funding for the Department of Agriculture (Biotechnology Regulatory Services (APHIS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service) Agriculture Research Service, Biofuels (Rural Development) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research & Development Authority (BARDA) Energy and Water Development and Related Agencies Appropriations Act for FY 2009 Funding for Biofuels Financial Services and General Government Appropriations Act for FY 2009 Sarbanes Oxley Reform Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009 Funding for Technology Innovation Program (TIP) Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2009 Funding for Biotechnology Research and Development Programs at the Agency for International Development Department of the Interior, Environment, and Related Agencies Appropriations for FY 2009 Funding for the Environmental Protection Agency
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2008 · first_quarter · Q1
Small Business Innovation and Research Program (SBIR) Reauthorization Act Venture-Backed Firm Eligibility Sarbanes-Oxley Reform Section 404 SEC and PCAOB Guidance on Auditing Standard (AS-5) Financial Services and General Government Appropriations Act for FY 2009 FDA Regulatory Processes for First-Time Filers
Stem Cell Research S.5 Small Business Innovation and Research Program (SBIR) Reauthorization Act Venture-Backed Firm Eligibility R&D Tax Credit Extension of Expired R&D Tax Credit Technology Innovation Program (TIP) Proposed Rules Funding -Departments of Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2007 · year_end · YA
Small Business Innovation and Research Program (SBIR) H.R. 2720 H.R. 3567 Sarbanes-Oxley Reform Section 404 SEC and PCAOB Guidance on Auditing Standard (AS-5) FDA Waivers for Small Businesses H.R. 3580; H.R. 2900; S. 1082 FDA Regulatory Processes for First-Time Filers
Stem Cell Research Small Business Innovation and Research Program (SBIR) H.R. 2720 H.R. 3567 R&D Tax Credit (H.R. 2764) Extension Permanence Alternatives Infectious Disease Tax Credit S. 2351
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2007 · year_end · YY
Small Business Innovation and Research Program (SBIR) H.R. 2720 H.R. 3567
Sarbanes-Oxley Reform Section 404 SEC and PCAOB Guidance on Auditing Standard (AS-5)
Biobased Products Tax Credits H.R. 2419 H.R. 3586
Biofuels (Non-Funding) --Production Tax Credit Extension --S. 2658: Federal Aviation Administration Reauthorization Act of 2016 ----Franken-Grassley Amendment Research & Development Tax Credit Reforms --Extension --Permanency --Refundable R&D Credit Capital Formation Investment Incentives --H.R. 2179: PARTNER Act --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act Tax Reform --Innovation Box / Patent Box Orphan Drug Act Tax Credit Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act Inversions --Financial Services and General Government Appropriations Act for FY 2017 Renewable Chemicals/Bio-based Products (Non-Funding) --Investment Tax Credit for Renewable Chemicals and Bio-based Products --S. 2271: The Renewable Chemicals Act --S. 1656/H.R. 2883: Master Limited Partnership Parity Act --H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act  
Sarbanes Oxley Section 404 (b) --PCAOB Audit Cost Increases --H.R. 4139: Fostering Innovation Act XBRL Exemption for Small Public Companies --H.R. 1965: Small Company Disclosure Simplification Act --H.R. 1675: Capital Markets Improvement Act Capital Market Enhancements --H.R. 1675: Encouraging Employee Ownership Act --H.R. 4168: Small Business Capital Formation Enhancement Act --H.R. 3784: Securities & Exchange Commission Small Business Advocate Act --H.R. 1675: Capital Markets Improvement Act --H.R. 2354: Streamlining Excessive and Costly Regulations Review Act --H.R. 4638: Main Street Growth Act Proxy Advisory Services --Impact of Policies on Small Public Companies --Proxy Advisory Firm Reform Act (Discussion Draft) Reform of SEC Regulation D --S. 978/H.R. 4498: HALOS Act Short Selling Transparency Capital Formation Investment Incentives --H.R. 2179: PARTNER Act --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)
Sarbanes Oxley Section 404 (b) ---H.R. 4139: the Fostering Innovation Act Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act ---H.R. 2179: PARTNER Act Reform of SEC Regulation D ---S. 978: the HALOS Act Expansion of Exemption under SEC Regulation A ---H.R. 1839: Reforming Access for Investments in Startup Enterprises (RAISE) Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions XBRL Exemption for Small Public Companies ---H.R. 5405: Promoting Job Creation and Reducing Small Business Burdens Act ---H.R. 1965: Small Company Disclosure Simplification Act Capital Market Enhancements ---H.R. 1525: Disclosure Modernization and Simplification Act ---H.R. 1723: Small Company Simple Registration Act ---H.R. 2064: Improving Access to Capital for Emerging Growth Companies Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 3784: Securities & Exchange Commission Small Business Advocate Act -- H.R. 2357: Accelerating Access to Capital Act Proxy Advisory Services ---Impact of Policies on Small Public Companies
Renewable Chemicals/Bio-based Products ---S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act Biofuels (Non-Funding) ---Accelerated Depreciation Extension ---Production Tax Credit Extension ---H.R.2029: Consolidated Appropriations Act for FY 2016 ------Protecting Americans from Tax Hikes (PATH) Act of 2015 Research & Development Tax Credit Reforms ---Extension ---Permanency ---Refundable R&D Credit ---H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities ---S. 537: COMPETE Act ---S. 341: Start-up Jobs and Innovation Act ---H.R.2029: Consolidated Appropriations Act for FY 2016 ------Protecting Americans from Tax Hikes (PATH) Act of 2015 Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Capital Formation Investment Incentives ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 537: COMPETE Act ---S. 341: Start-up Jobs and Innovation Act ---H.R. 2179: PARTNER Act Tax Reform ---Innovation Box/Patent Box Orphan Drug Act Tax Credit Controlled Foreign Corporation Look-Through Rule Extension ---H.R.2029: Consolidated Appropriations Act for FY 2016 ------Protecting Americans from Tax Hikes (PATH) Act of 2015 Inversions ---H.R.2029: Consolidated Appropriations Act for FY 2016
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)
Renewable Chemicals/Bio-based Products --Expansion of Master Limited Partnerships to Renewable Chemicals --New Production Tax Credit --S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act --H.R. 2833/S.1656: Master Limited Partnerships Parity Act of 2015 Biofuels --Production Tax Credit Extension --S.2089: American Energy Innovation Act Research & Development Tax Credit Reforms --Extension --Permanency --Refundable R&D Credit --H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act Capital Formation Investment Incentives --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act --H.R. 2179: PARTNER Act Tax Reform --Innovation Box/Patent Box Orphan Drug Act Tax Credit Inversions --H.R. 2995/S.1910: Department of Financial Services and Related Agencies Appropriations Act for FY 2016 Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act
Biosimilars --Biosimilar User Fee Act Implementation --Coding --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Reimbursement Policy Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development and Procurement Issues (Non-funding) TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues --Regulatory Harmonization Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 Drug Evaluation and Review --Compassionate Use/Expanded Access --Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Senate Innovation for Healthier Americans Initiative --Biomarkers and Regulatory Science Improvements --Combination Products --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Information Disclosures --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --PATH Act (Senate Discussion Draft) House 21st Century Cures Initiative --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence Vaccines and Infectious Diseases - General Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Government Price Reporting --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Gene Editing Technologies --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -----Report Language on Heritable Genetic Modification Restriction NIH Precision Medicine Initiative Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Renewable Chemicals/Bio-based Products --New Production Tax Credit --Expansion of Master Limited Partnerships to Renewable Chemicals --H.R. 2833/S.1656: Master Limited Partnerships Parity Act of 2015 Biofuels --Production Tax Credit Extension Research & Development Tax Credit Reforms --Extension --Permanency --H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities --S. 537: COMPETE Act Capital Formation Investment Incentives --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act --H.R. 2179: PARTNER Act Tax Reform --Innovation/Patent Box Orphan Drug Act Tax Credit Inversions --H.R. 2995: Department of Financial Services and Related Agencies Appropriations Act for FY 2016
Sarbanes Oxley Section 404 (b) --Public Company Accounting Oversight Board - Audit Cost Increases Capital Formation Investment Incentives --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --H.R. 2179: PARTNER Act --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act Expansion of Exemption under SEC Regulation A --H.R. 1839: Reforming Access for Investments in Startup Enterprises (RAISE) Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions --Fostering Innovation Act (House Discussion Draft) XBRL Exemption for Small Public Companies --H.R. 1965: Small Company Disclosure Simplification Act --H.R. 37: Promoting Job Creation and Reducing Small Business Burdens Act Capital Market Enhancements --SEC Office of Small Business Policy Responsibilities --H.R. 1525: Disclosure Modernization and Simplification Act --H.R. 1675/S.576: Encouraging Employee Ownership Act --H.R. 1723: Small Company Simple Registration Act --H.R. 2064: Improving Access to Capital for Emerging Growth Companies Act --H.R. 2357: Accelerating Access to Capital Act Proxy Advisory Services --Impact of Policies on Small Public Companies
Biosimilars --Naming --Interchangeability and Pharmacy Substitution --Implementation of Affordable Care Act --Patent Certification --Reimbursement Policy Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Funding for FDA --H.R. 3049/S. 1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --HR 1078: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Drug Evaluation and Review --Implementation of the FDA Safety and Innovation Act/Prescription Drug User Fee Act Orphan Drug Act Tax Credit 21st Century Cures Initiative --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals and Payers --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculation --Reimbursement for Infusion Drugs under Medicare Part B Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)
Sarbanes Oxley Section 404 (b) -Public Company Accounting Oversight Board Audit Cost Increases Capital Formation Investment Incentives -Reform of Capital Gains Rules -Reform of Net Operating Loss Rules -Reform of Passive Loss Rules -PARTNER Act (House Discussion Draft) -S. 341: Start-up Jobs and Innovation Act -S. 537: COMPETE Act Expansion of Exemption under SEC Regulation A - Proposed Legislation -Proposed SEC Rule on Reg A+ Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions -Fostering Innovation Act (House Discussion Draft) XBRL Exemption for Small Public Companies -H.R. 37: Promoting Job Creation and Reducing Small Business Burdens Act -Small Company Disclosure Simplification Act (House Discussion Draft) Stock Exchange Tick Size -H.R. 37: Promoting Job Creation and Reducing Small Business Burdens Act Capital Market Enhancements -H.R. 1525: Disclosure Modernization and Simplification Act -H.R. 1723: Small Company Simple Registration Act -S. 576: Encouraging Employee Ownership Act -SEC Office of Small Business Policy Responsibilities -Small Business Freedom to Grow Act (House Discussion Draft) -Improving Access to Capital for Emerging Growth Companies Act (House Discussion Draft)
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Sarbanes Oxley Section 404 (b) -Public Company Accounting Oversight Board Audit Cost Increases Capital Formation Investment Incentives -Reform of Capital Gains Rules -Reform of Net Operating Loss Rules -Reform of Passive Loss Rules -PARTNER Act (House Discussion Draft) -S. 341: Start-up Jobs and Innovation Act -S. 537: COMPETE Act Expansion of Exemption under SEC Regulation A - Proposed Legislation -Proposed SEC Rule on Reg A+ Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions -Fostering Innovation Act (House Discussion Draft) XBRL Exemption for Small Public Companies -H.R. 37: Promoting Job Creation and Reducing Small Business Burdens Act -Small Company Disclosure Simplification Act (House Discussion Draft) Stock Exchange Tick Size -H.R. 37: Promoting Job Creation and Reducing Small Business Burdens Act Capital Market Enhancements -H.R. 1525: Disclosure Modernization and Simplification Act -H.R. 1723: Small Company Simple Registration Act -S. 576: Encouraging Employee Ownership Act -SEC Office of Small Business Policy Responsibilities -Small Business Freedom to Grow Act (House Discussion Draft) -Improving Access to Capital for Emerging Growth Companies Act (House Discussion Draft)
Biofuels -Production Tax Credit Extension Research & Development Tax Credit Reforms -Permanency -Extension -S. 537: COMPETE Act -S. 341: Start-up Jobs and Innovation Act Capital Formation Investment Incentives -Reform of Capital Gains Rules -Reform of Net Operating Loss Rules -Reform of Passive Loss Rules -S. 341: Start-up Jobs and Innovation Act -S. 537: COMPETE Act -PARTNER Act (House Discussion Draft) Renewable Chemicals/Bio-based Products -New Production Tax Credit -Expansion of Master Limited Partnerships to Renewable Chemicals Tax Reform Orphan Drug Act Tax Credit
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Renewable Chemicals/Bio-based Products S. 2260: EXPIRE Act of 2014Biofuels Accelerated Depreciation Extension Production Tax Credit Extension S. 2260: EXPIRE Act of 2014 Research & Development Tax Credit Reforms Extension Permanency H.R. 4438: American Research & Competitiveness Act of 2014 H.R.119: To amend the Internal Revenue Code to make permanent the credit for increasing research activities S. 2260: EXPIRE Act of 2014 S. 2715: The COMPETE Act S. 193: The Start-up Innovation Credit Act Capital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules S. 2260: EXPIRE Act of 2014 H.R. 4855, the PARTNER Act S. 1658: The Start-up Jobs and Innovation Act HR 4855: To amend the Internal Revenue Code of 1986 to provide an exception from the passive loss rules for investments in high technology research small business pass-thru entities Tax Reform Orphan Drug Act Tax Credit Controlled Foreign Corporation Look-Through Rule Extension S. 2260: EXPIRE Act of 2014 Inversions H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015
Affordable Care Act Implementation Third Party Support of Patient Premiums and Cost-Sharing Obligations21st Century Cures Initiative Biomarkers and Regulatory Science Improvements Communication with Healthcare Professionals Expanded Access to Investigational Drugs Expedited Pathways FDA Hiring Flexibility FDA Management and Financial Accountability Innovation Incentives Longitudinal Study of Chronic Diseases Patient Access to Approved Drugs Patient-Focused Drug Development Use of Real-World Evidence Vaccine and Anti-Microbial Resistance Product Development and Incentives Combating Antibiotic-Resistant Bacteria (CARB) Initiative Biosimilars Biosimilar User Fee Act Implementation Colombia Biologics Regulations Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Naming Patent Certification Funding for National Institutes of Health H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 340B Drug Pricing Program H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Implementation of Affordable Care Act Program Implementation & Oversight Funding for FDA H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 TransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Regulatory Harmonization Reimbursement Issues Intellectual Property IssuesReimbursement for Innovative Products H.R. 1416: Cancer Patient Protection Act of 2013 Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes Sequestration of PDUFA Fees HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Drug Evaluation and Review Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Clinical Trial Data Sharing and Disclosure Canadian Policies European Policies Sunshine Act Implementation
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR), White House Office
Sarbanes Oxley Section 404 (b) Mandatory Audit Firm Rotation H.R. 1564/S. 1526: The Audit Integrity and Job Protection ActCapital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules S. 1658: The Start-up Jobs and Innovation Act H.R. 4855: The PARTNER Act S.2715: The COMPETE Act Expansion of Exemption under SEC Regulation A H.R. 4565: Startup Capital Modernization Act Proposed SEC Rule on Reg A+ Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions H.R. 2629: The Fostering Innovation Act XBRL Exemption for Small Public Companies H.R. 4164: Small Company Disclosure Simplification Act H.R. 5405: The Promoting Job Creation and Reducing Small Business Burdens Act Stock Exchange Tick Size H.R. 3448: The Small Cap Liquidity Reform Act H.R. 1952: The Spread Pricing Liquidity Act Capital Market Enhancements H.R. 3623: Improving Access to Capital for Emerging Growth Companies Act H.R. 4568: Small Business Freedom to Grow Act H.R. 4569: Disclosure Modernization and Simplification Act H.R. 4571: To direct the SEC to revise its rules so as to increase the threshold amount for requiring issuers to provide certain disclosures relating to compensatory benefits plans H.R. 4697: To require the SEC to revise the definition of a WKSI to reduce the worldwide market value threshold under the definition
Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015Biosimilars Naming Colombia Biologics Regulations Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Vaccine Access/Financing Implementation of Affordable Care Act S.2694: Ensuring Access to Primary Care for Women and Children Act 340B Drug Pricing Program Implementation of Affordable Care Act Program Implementation & Oversight Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Funding for FDA H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes Sequestration of PDUFA Fees S. 1413: FDA User Fee Protection Act Drug Evaluation and Review Compassionate Use/Expanded Access Special Medical Use/Limited Population Drug Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Clinical Trial Data Sharing and Disclosure EU Policies Canadian Policies Sunshine Act Implementation Affordable Care Act Implementation Third Party Support of Patient Premiums and Cost-Sharing Obligations 21st Century Cures InitiativeTransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Regulatory Harmonization Reimbursement Transparency Intellectual Property Issues
Filing targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)
Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015Biosimilars Colombia Biologics Regulations Naming Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Vaccine Access/Financing Adult Immunization (Senate Discussion Draft) 340B Drug Pricing Program Implementation of Affordable Care Act Program Implementation & Oversight Departments of Labor, HHS, Education and Related Agencies Appropriations Act for FY 2015 Drug Importation H.R. 4660: Commerce, Justice, Science and Related Agencies Appropriations Act for FY 2015 Funding for FDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Medicaid Pricing and Rebates Implementation of Affordable Care Act H.R. 1416: The Cancer Patient Protection Act of 2013 National Center for Advancing Translational Science (NCATS) (Non-Funding) Program Implementation Sequestration of PDUFA Fees Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2015 HR 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act TransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade & Investment Partnership Regulatory Harmonization/TransparencyDrug Evaluation and Review Implementation of the FDA Safety and Innovation Act 21st Century Cures Initiative Compassionate Use/Expanded Access FDA Proposed Rule on Changes to Drug Labeling Special Medical Use/Limited Population Drugs H.R. 4475: Compassionate Freedom of Choice Act H.R. 2090: The Patient Choice Act H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Orphan Drug Act Tax Credit Clinical Trial Data Sharing and Disclosure EU Policies Drug Manufacturing, Quality & Distribution Implementation of H.R. 3204: The Drug Quality and Security Act Compounding Sunshine Act Implementation Medicare Physician Payment Sustainable Growth Rate Formula S. 2110: Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014 Drug Repurposing H.R. 4287/S.2150: Independent Innovator and Repurposing Act
Sarbanes Oxley Section 404 (b) Mandatory Audit Firm Rotation H.R. 1564/S. 1526: The Audit Integrity and Job Protection ActCapital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules H.R. 4855: The PARTNER Act S. 1658: The Start-up Jobs and Innovation Act The COMPETE Act (Senator Carper Discussion Draft) House Ways & Means Committee Discussion Draft (Rep. Camp) Reform of SEC Regulation D Implementation of Jumpstart Our Business Start-ups (JOBS) Act H.R. 4554: Restricted Securities Relief Act H.R. 4570: Private Placement Improvement Act Expansion of Exemption under SEC Regulation A H.R. 4565: Start-up Capital Modernization Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions H.R. 2629: The Fostering Innovation Act Small Business Innovation Research (SBIR) Program XBRL Exemption for Small Public Companies H.R. 4164: Small Company Disclosure Simplification Act Stock Exchange Tick Size H.R. 3448: The Small Cap Liquidity Reform Act H.R. 1952: The Spread Pricing Liquidity Act Capital Market Enhancements H.R. 4568: Small Business Freedom to Grow Act H.R. 4571: To direct the SEC to revise its rules so as to increase the threshold amount for requiring issuers to provide certain disclosures relating to compensatory benefits plans H.R. 3623: Improving Access to Capital for Emerging Growth Companies Act H.R. 4569: Disclosure Modernization and Simplification Act H.R. 4697: To require the SEC to revise the definition of a WKSI to reduce the worldwide market value threshold under the definition
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)
Biofuels Accelerated Depreciation Extension Production Tax Credit ExtensionRenewable Chemicals/Bio-based Products New Production Tax Credit for Renewable Chemicals S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act Bonus Depreciation for Renewable Chemical Facilities Research & Development Tax Credit Reforms Extension Permanency The Start-up Innovation Credit Act (Senator Coons Discussion Draft) The Innovative Research and Competitiveness Act (Senator Carper Discussion Draft) Capital Formation Investment Incentives Reform of Passive Loss Rules Reform of Net Operating Loss Rules Reform of Capital Gains Rules S. 1658: The Start-up Jobs and Innovation Act House Ways and Means Committee Discussion Draft (Rep. Camp) Tax Reform House Ways and Means Committee Discussion Draft (Rep. Camp) Orphan Drug Act Tax Credit Controlled Foreign Corporation Look-Through Rule Extension
Capital Market Enhancements H.R. 3623: Improving Access to Capital for Emerging Growth Companies ActSarbanes Oxley Section 404 (b) Mandatory Audit Firm Rotation H.R. 1564/S. 1526: The Audit Integrity and Job Protection Act Capital Formation Investment Incentives Reform of Passive Loss Rules Reform of Net Operating Loss Rules Reform of Capital Gains Rules S. 1658: The Start-up Jobs and Innovation Act Reform of SEC Regulation D Implementation of Jumpstart Our Business Start-ups (JOBS) Act Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions H.R. 2629: The Fostering Innovation Act XBRL Exemption for Small Public Companies H.R. 4164: Small Company Disclosure Simplification Act Stock Exchange Tick Size H.R. 3488: The Small Cap Liquidity Reform Act
Filing targets: Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)
Biofuels Production Tax Credit Extension Accelerated Depreciation ExtensionRenewable Chemicals/Bio-based Products Expansion of Master Limited Partnerships to Renewable Chemicals New Production Tax Credit for Renewable Chemicals S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act H.R. 1696/S. 795: Master Limited Partnerships Parity Act Research & Development Tax Credit Reforms Startup Innovation Credit (Senator Coons Discussion Draft) Innovative Research and Competitiveness Act (Senator Carper Discussion Draft) H.R.119: To amend the Internal Revenue Code to make permanent the credit for increasing research activities Capital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules H.R. 6559/S.3595: High Technology Small Business Research Incentives Act Tax Reform Orphan Drug Act Issues Tax Credit
Stock Exchange Tick Size Tick Size Flexibility Act (Rep. Duffy Discussion Draft) H.R. 1952: The Spread Pricing Liquidity ActSarbanes Oxley Section 404 (b) Mandatory Audit Firm Rotation H.R. 1564: The Audit Integrity and Job Protection Act S. 1526: The Audit Integrity and Job Protection Act Capital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules H.R. 6559/S.3595: High Technology Small Business Research Incentives Act Reform of SEC Regulation D Implementation of Jumpstart Our Business Start-ups (JOBS) Act Expansion of Exemption Under SEC Regulation A H.R. 701: To amend a provision of the Securities Act of 1933 directing the Securities and Exchange Commission to add a particular class of securities to those exempted under such Act to provide a deadline for such action Rep. McHenry Discussion Draft Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions H.R. 2629: Fostering Innovation Act Market Structure Reform for Small Companies XBRL Exemption for Small Public Companies
Filing targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Sarbanes Oxley Section 404 (b) Mandatory Audit Firm Rotation H.R. 1564/S. 1526: The Audit Integrity and Job Protection ActCapital Formation Investment Incentives Reform of Passive Loss Rules Reform of Net Operating Loss Rules Reform of Capital Gains Rules S. 1658: The Start-up Jobs and Innovation Act Reform of SEC Regulation D Implementation of Jumpstart Our Business Start-ups (JOBS) Act Expansion of Exemption under SEC Regulation A H.R. 701: To amend a provision of the Securities Act of 1933 directing the Securities and Exchange Commission to add a particular class of securities to those exempted under such Act to provide a deadline for such action Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions H.R. 2629: The Fostering Innovation Act XBRL Exemption for Small Public Companies Small Company Disclosure Simplification Act (Reps. Hurt and Sewell Discussion Draft) Stock Exchange Tick Size H.R. 1952: The Spread Pricing Liquidity Act H.R. 3488: The Small Cap Liquidity Reform Act
Filing targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)
Biofuels Production Tax Credit Extension Accelerated Depreciation Extension H.R. 3758: Second Generation Biofuel Extension Act of 2013Renewable Chemicals/Bio-based Products Investment Tax Credit for Renewable Chemicals and Bio-based Products New Production Tax Credit for Renewable Chemicals Expansion of Master Limited Partnerships to Renewable Chemicals H.R. 1696/S. 795: Master Limited Partnerships Parity Act S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act Research & Development Tax Credit Reforms Extension Permanency H.R.119: To amend the Internal Revenue Code to make permanent the credit for increasing research activities H.R.3757: The Igniting American Research Act The Innovative Research and Competitiveness Act (Senator Carper Discussion Draft), The Start-up Innovation Credit Act (Senator Coons Discussion Draft) Capital Formation Investment Incentives Reform of Passive Loss Rules Reform of Net Operating Loss Rules Reform of Capital Gains Rules S. 1658: The Start-up Jobs and Innovation Act Tax Reform Orphan Drug Act Tax Credit
Filing targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)
Stock Exchange Tick Size Tick Size Flexibility Act (Rep. Duffy Discussion Draft) H.R. 1952: The Spread Pricing Liquidity ActSarbanes Oxley Section 404 (b) Mandatory Audit Firm Rotation H.R. 1564: The Audit Integrity and Job Protection Act S. 1526: The Audit Integrity and Job Protection Act Capital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules H.R. 6559/S.3595: High Technology Small Business Research Incentives Act Reform of SEC Regulation D Implementation of Jumpstart Our Business Start-ups (JOBS) Act Expansion of Exemption Under SEC Regulation A H.R. 701: To amend a provision of the Securities Act of 1933 directing the Securities and Exchange Commission to add a particular class of securities to those exempted under such Act to provide a deadline for such action Rep. McHenry Discussion Draft Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions H.R. 2629: Fostering Innovation Act Market Structure Reform for Small Companies XBRL Exemption for Small Public Companies
Biofuels Production Tax Credit Extension Accelerated Depreciation ExtensionRenewable Chemicals/Bio-based Products Expansion of Master Limited Partnerships to Renewable Chemicals New Production Tax Credit for Renewable Chemicals S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act H.R. 1696/S. 795: Master Limited Partnerships Parity Act Research & Development Tax Credit Reforms Startup Innovation Credit (Senator Coons Discussion Draft) Innovative Research and Competitiveness Act (Senator Carper Discussion Draft) H.R.119: To amend the Internal Revenue Code to make permanent the credit for increasing research activities Capital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules H.R. 6559/S.3595: High Technology Small Business Research Incentives Act Tax Reform Orphan Drug Act Issues Tax Credit
Filing targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Sarbanes Oxley Section 404 (b) Mandatory Audit Firm Rotation (Rep. Hurt Discussion Draft) Tax ReformCapital Formation Investment Incentives High Technology Small Business Research Incentives Act (Discussion Draft) Expansion of Exemption Under SEC Regulation A H.R. 701: To amend a provision of the Securities Act of 1933 directing the Securities and Exchange Commission to add a particular class of securities to those exempted under such Act to provide a eadline for such action Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions Small Business Innovation Research (SBIR) Program Implementation of Final Rulemaking
Filing targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Filing targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Vaccine Access/Financing Tax for Seasonal Influenza Funding Taxable Vaccines Act (Discussion Draft) Tax Reform Bio-based Products Tax Credit S. 3491/H.R. 4953: Qualifying Renewable Chemical Production Tax Credit Act of 2012 Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Extension Pharmaceutical Industry Annual Fee Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Treasury and IRS Regulations Implementing the Law Biofuels Biofuels Production Tax Credit Modification for Algae-based Biofuels Biofuels Production Tax Credit Extension S. 3521: Family and Business Tax Cut Certainty Act of 2012 Research & Development Tax Credit Extension Innovative Research and Competitiveness Act (Senator Carper Discussion Draft) Startup Innovation Credit (Senator Coons Discussion Draft) Capital Formation Investment Incentives H.R. 6599/S.3595: High Technology Small Business Research Incentives Act of 2012 Renewable Chemicals S. 3491/H.R. 4953: Qualifying Renewable Chemical Production Tax Credit Act of 2012 S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S. 1764: Make It in America Tax Credit Act of 2011
Research & Development Tax Credit Extension Innovative Research and Competitiveness Act (Senator Carper Discussion Draft) Startup Innovation Credit (Senator Coons Discussion Draft) Small Business Innovation Research (SBIR) Program Rulemaking
Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions H.R. 6161: Fostering Innovation Act Reform of SEC Regulation D Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Extension Capital Formation Investment Incentives H.R. 6599/S.3595: High Technology Small Business Research Incentives Act of 2012 Small Business Innovation Research (SBIR) Program Rulemaking
Filing targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Navy, Dept of, Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), U.S. Trade Representative (USTR), White House Office
Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions H.R. 6161: Fostering Innovation Act Reform of SEC Regulation D Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Extension Capital Formation Investment Incentives H.R. 6599/S.3595: High Technology Small Business Research Incentives Act of 2012 Small Business Innovation Research (SBIR) Program Rulemaking
Pharmaceutical Industry Annual Fee Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Treasury and IRS Regulations Implementing the Law Biosimilars Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Colombia Biologics Regulations Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translations Science (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Vaccine Access/Financing Tax for Seasonal Influenza Funding Taxable Vaccines Act (Discussion Draft) 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Average Manufacturer Price Calculations Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Access to External Experts Conflicts of Interest Drug Shortages E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discussion Draft) Expedited Approval Pathways FDA Mission Regulatory Reforms for Innovative Products Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development, and Procurement HHS Countermeasures Review S.1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Reimbursement for Innovative Products Medicare Part D Prescription Drug Program Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act
Filing targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Navy, Dept of, Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), U.S. Trade Representative (USTR), White House Office
Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions Small Business Innovation Research (SBIR) Program Rulemaking Therapeutic Discovery Project Tax Credit Extension S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Capital Formation Investment Incentives
Filing targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Navy, Dept of, Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
Vaccine Access/Financing Tax for Seasonal Influenza Funding Bio-based Products Tax Credit Therapeutic Discovery Project Tax Credit Extension Biofuels Biofuels Production Tax Credit Modification for Algae-based Biofuels Biofuels Production Tax Credit Extension Research & Development Tax Credit Extension H.R. 3606: Jumpstart Our Business Start-ups (JOBS) Act Capital Formation Investment Incentives Renewable Chemicals New Production Tax Credit/Revisions to Existing Tax Credits
Biosimilars Biosimilars User Fee Act of 2012 (Discussion Draft) Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center of Advancing Translational Science (NCATS) Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Vaccine Access/Financing Adult Immunization Policies Tax for Seasonal Influenza Funding 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Therapeutic Discovery Project Tax Credit Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft FDA Globalization Act (Discussion Draft) H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.4132: Faster Access to Specialized Treatments (FAST) Act H.R.3206: Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement S 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Reimbursement for Innovative Products Medicare Part B Physician-Administered Products
Filing targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Navy, Dept of, Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
Biorefineries Next Generation Incentive Tax Credits Bio-based Products Tax Credit Therapeutic Discovery Project Tax Credit Extension Biofuels Investment Tax Credit Options Biofuels Production Tax Credit Modification for Algae-based Biofuels Biofuels Production Tax Credit Extension Research & Development Tax Credit Extension H.R. 942: American Research and Competitiveness Act of 2011 S. 1577: Greater Research Opportunities With Tax Help Act of 2011 Capital Formation Investment Incentives Renewable Chemicals New Production Tax Credit/Revisions to Existing Tax Credits
Shareholder Reporting Threshold S. 1824/H.R. 2167: Private Company Flexibility and Growth Act of 2011 Small Business Innovation and Research (SBIR) Program Reauthorization S.493: SBIR/STTR Reauthorization Act of 2011 H.R. 1425: Creating Jobs Through Small Business Innovation Act of 2011 H.R. 1540: National Defense Authorization Act for FY 2012 Sarbanes Oxley Section 404 (b) H.R. 3213: Small Company Job Growth and Regulatory Relief Act of 2011 S. 1933/H.R. 3606: Reopening American Capital Markets to Emerging Growth Companies Act of 2011 Therapeutic Discovery Project Tax Credit Extension Capital Formation Investment Incentives Expansion of Exemption Under SEC Regulation A S. 1544/H.R. 1070: The Small Company Capital Formation Act of 2011 Reform of SEC Regulation D S. 1831/H.R. 2940: Access to Capital for Job Creators Act of 2011
Filing targets: Agriculture, Dept of (USDA), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Navy, Dept of, Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
Medicaid Rebates Dual Eligibles Generic Fill Incentives Medicare Prescription Drug Coverage Transfer of Certain Drugs from Part B to Part D Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Biosimilars Implementation of H.R. 3590:(Senate) Patient Protection and Affordable Care Act Reimbursement Issues Funding for National Institutes of Health S.R. 1599: Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for FY 2012 Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 1599: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 Expansion of 340B Drug Pricing Program Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Diagnostics and Personalized Medicine Regulation and Oversight Therapeutic Discovery Project Tax Credit Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review S. 1584: Drug Safety and Accountability Act of 2011 Prescription Drug User Fee Act (PDUFA) Reauthorization Regulatory Reforms for Innovative Products Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 2112: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2012 Independent Payment Advisory Board Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 1599: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 Cures Acceleration Network S. 1599: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 Biodefense Research, Development and Procurement (Non-Funding Issues) Pandemic and All-Hazards Preparedness Act Reauthorization HHS Countermeasures Review Drug Shortages H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 S. 296: Preserving Access to Life-Savings Medicines Act of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Reimbursement for Innovative Products Part B Physician-Administered Products Medicare Policies and Regulation
Filing targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Navy, Dept of, Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)
Medicare Prescription Drug Coverage Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 Vaccine Access/Financing S. 1094: Combating Autism Reauthorization Act Expansion of 340B Drug Pricing Program Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Medicaid Rebates Dual Eligibles Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Diagnostics and Personalized Medicine Regulation and Oversight Therapeutic Discovery Project Tax Credit Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review Regulatory Reforms for Innovative Products Prescription Drug User Fee Act (PDUFA) Reauthorization Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 1/H.J. RES 92: Continuing Appropriations Act for FY 2011 H.R. 2112: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2012 Independent Payment Advisory Board Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Repeal Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2012 H.J. RES.48: Department of Defense and Further Additional Continuing Appropriations Act for FY 2011 H.R. 1/H.J. RES.92: Continuing Appropriations Act for FY 2011 Cures Acceleration Network Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Biodefense Research, Development and Procurement HHS Countermeasures Review Pandemic and All-Hazards Preparedness Act Reauthorization Drug Shortages S. 296: Preserving Access to Life-Savings Medicines Act of 2011 H.R. 2245: Preserving Access to Life Saving Medicines Act of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Reimbursement for Innovative Products Medicare Policies and Regulation
Filing targets: Agriculture, Dept of (USDA), Air Force, Dept of, Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Internal Revenue Service (IRS), Natl Institutes of Health (NIH), Navy, Dept of, Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Small Business Innovation and Research (SBIR) Program Reauthorization S.493: SBIR/STTR Reauthorization Act of 2011 Sarbanes Oxley Section 404 (b) Exemption Therapeutic Discovery Project Tax Credit Extension Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Council of Economic Advisers (CEA), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Intl Trade Administration (ITA), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Institutes of Health (NIH), Natl Security Council (NSC), Navy, Dept of, Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Secretary of Defense, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Treasury, Dept of, U.S. Customs & Border Protection, U.S. Trade Representative (USTR)
Small Business Innovation and Research (SBIR) Program Reauthorization H.R. 2965/S.1233: Enhancing Small Business Research and Innovation Act of 2009 S. 4053: SBIR/STTR Reauthorization Act of 2010 Sarbanes Oxley Section 404 (b) Exemption H.R. 4173: Wall Street Reform and Consumer Protection Act of 2009 Therapeutic Discovery Project Tax Credit Extension Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act
Biofuels Production Tax Credit Extension H.R. 5142: Grow Renewable Energy Economy Now-Jumpstart Other Biofuels Act of 2010 Biofuels Production Tax Credit Modification for Algae-based Biofuels H.R. 4168: Algae-based Renewable Fuel Promotion Act of 2010 H.R. 5142: Grow Renewable Energy Economy Now-Jumpstart Other Biofuels Act of 2010 Bio-based Products Tax Credit Therapeutic Discovery Project Tax Credit Extension Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Pharmaceutical Industry Annual Fee Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Treasury and IRS Regulations Implementing the Law Research & Development Tax Credit Extension H.R. 4853: Tax Relief, Unemployment Insurance Reauthorization, and Job Creation Act of 2010
Filing targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Navy, Dept of, Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Secretary of Defense, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Small Business Innovation and Research (SBIR) Program Reauthorization H.R. 2965/S.1233: Enhancing Small Business Research and Innovation Act of 2009 Therapeutic Discovery Project Tax Credit Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Small Business Early-Stage Investment H.R. 5297: Small Business Lending Fund Act of 2010
Drug Safety and Review FDA Globalization Act (Discussion Draft) E-Pedigree and Anti-Counterfeiting Biodefense Research, Development and Procurement S. 3761: A Bill to Restore Funding for Indian Loan Guarantee Program at the Bureau of Indian Affairs HHS Countermeasures Review H.R. 4899: Supplemental Appropriations Act of 2010 H.R. 5297: American Jobs and Closing Tax Loopholes Act of 2010 S. 3693: A Bill to Provide Funding for the Settlement of Lawsuits Against the Federal Government for Discrimination Against Black Farmers Pharmaceutical Industry Annual Fee Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Treasury and IRS Regulations Implementing the Law Medicare Prescription Drug Coverage Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Comparative Effectiveness Program Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Nomination of Board Members for the Patient-Centered Outcomes Research Institute Vaccine Access/Financing Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Expansion of 340B Drug Pricing Program H.R. 4213: American Jobs and Closing Tax Loopholes Act of 2010 S. 3793: Job Creation and Tax Cuts Act of 2010 Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Federal Supply Schedule Access During Emergencies S.2868: Federal Supply Schedules Usage Act of 2009 Alliance for Healthcare Competitiveness Stem Cell Research Federal Funding of Embryonic Stem Cell Research Medicaid Rebates Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Therapeutic Discovery Project Tax Credit Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Importation S. 3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 S. 3607: Department of Homeland Security Appropriations Act for FY 2011 S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Average Manufacturer Price Calculations H.R. 4213: American Jobs and Closing Tax Loopholes Act of 2010 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 Diagnostics and Personalized Medicine Regulation and Oversight Draft Legislation Rare Pediatric & Tropical Disease Drug Development S. 3697: Creating Hope Act of 2010 Funding for the Food and Drug Administration S. 3606: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2011 Funding for National Institutes of Health S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Cures Acceleration Network Funding: S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Pandemic Influenza Preparedness S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 4899: Emergency Supplemental Appropriations Act for FY 2010 H.R. 1586/S.A. 4575: Supplemental Education, Jobs and Medicaid Assistance Act for FY 2011 Funding for Bioterrorism and Emergency Preparedness S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 4899: Emergency Supplemental Appropriations Act for 2010 H.R. 1586/S.A. 4575: Supplemental Education, Jobs and Medicaid Assistance Act for FY 2011 Funding for Biomedical Advanced Research and Development Authority (BARDA) S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 H.R. 4899: Emergency Supplemental Appropriations Act for 2010 H.R. 1586/S.A. 4575: Supplemental Education, Jobs and Medicaid Assistance Act for FY 2011 Funding for Strategic National Stockpile S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 3686: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Interior, Dept of (DOI), Internal Revenue Service (IRS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Therapeutic Discovery Project Tax Credit Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Bio-based Products Tax Credits Biofuels Production Tax Credit Extension H.R. 5142: Grow Renewable Energy Economy Now- Jumpstart Other Biofuels Act of 2010 Biofuels Production Tax Credit Modification for Algae-based Biofuels H.R. 5142: Grow Renewable Energy Economy Now- Jumpstart Other Biofuels Act of 2010 H.R. 4168: Algae-based Renewable Fuel Promotion Act of 2009 S.1250: Algae-based Renewable Fuel Promotion Act of 2009 Biofuels Investment Tax Credit Option H.R. 5142: Grow Renewable Energy Economy Now- Jumpstart Other Biofuels Act of 2010 Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation Senate Substitute to H.R. 5297: Small Business Lending Fund Act of 2010 Modifications to Internal Revenue Code Section 1202 for Qualified Small Business Stock Incentive H.R. 4173: Wall Street Reform and Consumer Protection Act of 2009 Senate Financial Regulatory Reform Discussion Draft Research & Development Tax Credit Extension HR 4213: American Jobs and Closing Tax Loopholes Act of 2010
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Fish & Wildlife Service (USFWS), U.S. Trade Representative (USTR), White House Office
Healthcare Reform Comparative Effectiveness Research Program Initiatives Vaccine Access/Financing Health Care Reform Cont... Follow-on Biologics Reporting of Physician Payments Expansion of 340B Drug Pricing Program Generic Fill Incentives Therapeutic Discovery Project Tax Credit Pharmaceutical Fee Medicaid Rebates Drug Importation Cures Acceleration Network Medicare Prescription Drug Coverage H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act S. 1679: Affordable Health Choices Act of 2009 H.R. 4872: Health Care and Education Reconciliation Act of 2010 Drug Importation H.R. 3590: (Senate) Patient Protection and Affordable Care Act S.1796: America's Healthy Future Act of 2009 H.R. 4872: Health Care and Education Reconciliation Act of 2011 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations for FY 2011 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2011 Department of Homeland Security Appropriations Act for FY 2011 Funding for the Food and Drug Administration Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations for FY 2011 Stem Cell Research Medicaid Rebates S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act H.R. 4872: Health Care and Education Reconciliation Act of 2010 Generic Fill Incentives H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Medicare Prescription Drug Coverage H.R. 3590: (Senate) Patient Protection and Affordable Care Act Follow-on Biologics Reimbursement Issues S.1679: Affordable Health Choices Act of 2009 S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act H.R. 4872: Health Care and Education Reconciliation Act of 2010 Funding for Biomedical Advanced Research & Development Authority (BARDA) Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Comparative Effectiveness Program Initiatives H.R. 2502: Comparative Effectiveness Research Act of 2009 S.1213: Patient-Centered Outcomes Research Act of 2009 S.1796: American's Health Future Act of 2009 S.1679: Affordable Health Choices Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Funding for National Institutes of Health Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Cures Acceleration Network Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Funding for Strategic National Stockpile Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Reporting of Physician Payments S. 310: Physician Payments Sunshine Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act S.1796: American's Health Future Act of 2009 S.1679: Affordable Health Choices Act of 2009 Vaccine Access/Financing S.1796:America's Healthy Future Act of 2009 S.1679: America's Affordable Health Choices Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act S. 2868: Federal Supply Schedules Usage Act of 2009 S.1649: Weapons of Mass Destruction Preparedness Act of 2009 H.R. 4872: Health Care and Education Reconciliation Act of 2010 Expansion of 340B Drug Pricing Program S.1796:America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act H.R. 4872: Health Care and Education Reconciliation Act of 2010 Expanded Access to Experimental Products FDA Rules Development of Medical Countermeasures in Response to Bio-threats HHS Countermeasures Review Cures Acceleration Network H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2011 Alliance for Healthcare Competitiveness
Small Business Innovation and Research (SBIR) Program Reauthorization H.R. 2965/S.1233: Enhancing Small Business Research and Innovation Act of 2009 Therapeutic Discovery Project Tax Credit S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act H.R. 4872: Health Care and Education Reconciliation Act of 2010 Sarbanes Oxley Section 404 (b) Exemption H.R. 4173: Wall Street Reform and Consumer Protection Act of 2009 Senate Financial Regulatory Reform Discussion Draft Modifications to Internal Revenue Code Section 1202 for Qualified Small Business Stock Incentive
Filing targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Small Business Innovation and Research (SBIR) Program Reauthorization H.R. 2965/S.1233: Enhancing Small Business Research and Innovation Act of 2009 SBA Grant Proposal for Early Stage Investment H.R. 3738: Small Business Early-Stage Investment Act of 2009 H.R. 3854: Small Business Financing and Investment Act of 2009 Therapeutic Discovery Project Tax Credit S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3200: America's Affordable Health Choices Act of 2009 H.R. 3962: Affordable Health Care for America Act Small Business Definition in SEC Rule 12b-2 H.R. 4173: Wall Street Reform and Consumer Protection Act of 2009 Sarbanes Oxley Section 404 (b) Exemption H.R. 4173: Wall Street Reform and Consumer Protection Act of 2009
Therapeutic Discovery Project Tax Credit S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act H.R. 3962: Affordable Health Care for America Act Therapeutic Discovery Project Tax Credit Cont... H.R. 3200: America's Affordable Health Choices Act Bio-based Products Tax Credits H.R. 2454: American Clean Energy and Security Act of 2009 S. 1733: Clean Energy Jobs and American Power Act of 2009 Pharmaceutical Excise Tax S.1796: America's Healthy Future Act of 2009 H.R. 3590: (Senate) Patient Protection and Affordable Care Act Research and Development Tax Credit Extension H.R. 4213: Tax Extenders Act of 2009 Cellulosic Tax Credit Modification for Algae-based Biofuels S.1250: Algae-based Renewable Fuel Promotion Act of 2009
Filing targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)
Listing Requirements on Exchanges SEC Proposed Rules Small Business Definition Amendment Investor Protection Act of 2009 House Discussion Draft SEC Rule 12b-2
Therapeutic Development Investment Tax Credit Senate Finance Committee's America's Healthy Future Act of 2009 Tax Legislation Bio-based Products Tax Credits Pharmaceutical Excise Tax Senate Finance Committee's America's Healthy Future Act of 2009 R&D Tax Credit Extension
Small Business Innovation and Research (SBIR) Program Reauthorization H.R. 2965/S.1233: Enhancing Small Business Research and Innovation Act of 2009 SBA Grant Proposal for Early Stage Investment SBA Early Stage Investment Act of 2009 Discussion Draft FDA Regulatory Processes for First-Time Filers Listing Requirements on Exchanges SEC Proposed Rules Therapeutic Development Investment Tax Credit Tax Legislation Senate Finance Committee's America's Healthy Future Act of 2009 Small Business Definition Amendment Investor Protection Act of 2009 House Discussion Draft SEC Rule 12b-2
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Energy, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
Filing targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Stem Cell Research Small Business Innovation and Research Program (SBIR) H.R. 5819: SBIR Reauthorization Act R&D Tax Credit H.R. 6049 Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation H.R. 3221 Technology Transfer Policies Technology Innovation Program (TIP) Proposed Rules by National Institutes for Standards & Technology Funding --Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009
Sarbanes-Oxley Reform Section 404 SEC and PCAOB Guidance on Auditing Standard (AS-5) S.3260: Financial Services and General Government Appropriations Act for FY 2009 International Financial Reporting Standards Upcoming SEC Proposed Rules Net Operating Loss Limitation Reform/Internal Revenue Code Section 382 H.R. 3264: American Sciences Competitiveness Act Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation H.R. 3221
Filing targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Council of Economic Advisers (CEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Stem Cell Research Small Business Innovation and Research Program (SBIR) H.R. 5819: SBIR Reauthorization Act S.3362 Modification/Extension of R&D/AMT Tax Credits in Lieu of Bonus Depreciation H.R. 7327: Worker, Retiree, and Employer Recovery Act of 2008 S.1. American Recovery & Reinvestment Act of 2009 Technology Innovation Program (TIP) Funding S:3282: Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009
Biofuels Production Tax Credit Bio-Based Products Production Tax Credit Modification/Extension of R&D/AMT Tax Credits in Lieu of Bonus Depreciation H.R. 7327: Worker, Retiree, and Employer Recovery Act of 2008 S. 1: American Recovery & Reinvestment Act of 2009 Net Operating Losses Monetization Tax Proposal S.1: American Recovery & Reinvestment Act of 2009
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
Biofuels Tax Credit R&D Tax Credit H.R. 6049 H.R. 1424 Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation H.R. 3221 Comprehensive Biotechnology Tax Incentives Legislation H.R. 3264
Sarbanes-Oxley Reform Section 404 S.3260: Financial Services and General Government Appropriations Act for FY 2009 Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation H.R. 3221
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Sarbanes-Oxley Reform Section 404 SEC and PCAOB Guidance on Auditing Standard (AS-5) S.3260: Financial Services and General Government Appropriations Act for FY 2009 International Financial Reporting Standards Upcoming SEC Proposed Rules Net Operating Loss Limitation Reform/Internal Revenue Code Section 382 H.R. 3264: American Sciences Competitiveness Act Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation H.R. 3221
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Funding for the Food and Drug Administration (Human Drug, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 (Cont...) Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Service (APHIS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service), Agriculture Research Service, Biofuels (Rural Development)) Drug Importation Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research & Development Authority (BARDA) Drug Importation Energy and Water Development and Related Agencies Appropriations Act for FY 2009 Funding for Biofuels S.3260: Financial Services and General Government Appropriations Act for FY 2009 Sarbanes Oxley - Section 404 Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009 Funding for Technology Innovation Program (TIP) Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2009 Funding for Biotechnology Research and Development Programs at the Agency for International Development Department of the Interior, Environment, and Related Agencies Appropriations for FY 2009 Funding for the Environmental Protection Agency FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for the Food and Drug Administration (Human Drug, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) Funding for Biomedical Advanced Research & Development Authority (BARDA) Funding for USDA/APHIS Funding for Biorefinery Construction, Research & Development Department of Homeland Security Appropriations Act for FY 2009 Drug Importation
Filing targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Council of Economic Advisers (CEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Biofuels Tax Credit Implementation of the Renewable Fuels, Consumer Protection and Energy Efficiency Act of 2007 H.R. 2419 Bio-based Products Tax Credits R&D Tax Credit Extension of Expired R&D Tax Credit Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation S.12 H.R. 5140
Stem Cell Research S.5 Small Business Innovation and Research Program (SBIR) Reauthorization Act Venture-Backed Firm Eligibility R&D Tax Credit Extension of Expired R&D Tax Credit Technology Innovation Program (TIP) Proposed Rules Funding -Departments of Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009
Sarbanes-Oxley Reform Section 404 SEC and PCAOB Guidance on Auditing Standard (AS-5) Financial Services and General Government Appropriations Act for FY 2009
Small Business Innovation and Research Program (SBIR) Reauthorization Act Venture-Backed Firm Eligibility Sarbanes-Oxley Reform Section 404 SEC and PCAOB Guidance on Auditing Standard (AS-5) Financial Services and General Government Appropriations Act for FY 2009 FDA Regulatory Processes for First-Time Filers
Filing targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Stem Cell Research S.5 Small Business Innovation and Research Program (SBIR) Reauthorization Act Venture-Backed Firm Eligibility R&D Tax Credit Extension of Expired R&D Tax Credit Technology Innovation Program (TIP) Proposed Rules Funding -Departments of Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009
Small Business Innovation and Research Program (SBIR) Reauthorization Act Venture-Backed Firm Eligibility Sarbanes-Oxley Reform Section 404 SEC and PCAOB Guidance on Auditing Standard (AS-5) Financial Services and General Government Appropriations Act for FY 2009 FDA Regulatory Processes for First-Time Filers
Sarbanes-Oxley Reform Section 404 SEC and PCAOB Guidance on Auditing Standard (AS-5) Financial Services and General Government Appropriations Act for FY 2009
Filing targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Biofuels Tax Credit Implementation of the Renewable Fuels, Consumer Protection and Energy Efficiency Act of 2007 H.R. 2419 Bio-based Products Tax Credits R&D Tax Credit Extension of Expired R&D Tax Credit Election of R&D/AMT Tax Credits in Lieu of Bonus Depreciation S.12 H.R. 5140
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY2009 Funding for the Food and Drug Administration (Human Drug Review, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) Cont.... Funding for the Department of Agriculture (Biotechnology Regulatory Services (APHIS), Animal Care & Veterinary Services (APHIS), Trade Activities (Office of the Secretary & Food Safety Inspection Service) Agriculture Research Service, Biofuels (Rural Development) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Funding for National Institutes of Health Funding for Bioterrorism and Emergency Preparedness Funding for Pandemic Influenza Preparedness Funding for Biomedical Advanced Research & Development Authority (BARDA) Energy and Water Development and Related Agencies Appropriations Act for FY 2009 Funding for Biofuels Financial Services and General Government Appropriations Act for FY 2009 Sarbanes Oxley Reform Commerce, Justice, Science, and Related Agencies Appropriations Act for FY 2009 Funding for Technology Innovation Program (TIP) Department of State, Foreign Operations and Related Programs Appropriations Act for FY 2009 Funding for Biotechnology Research and Development Programs at the Agency for International Development Department of the Interior, Environment, and Related Agencies Appropriations for FY 2009 Funding for the Environmental Protection Agency
Sarbanes-Oxley Reform Section 404 SEC and PCAOB Guidance on Auditing Standard (AS-5) Financial Services and General Government Appropriations Act for FY 2009
Filing targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Animal Cloning Regulations Publication of FDA Draft Risk Assessment Study on Cloning of Livestock (H.R. 2419; H.R. 3161; H.R. 2764; S. 1859) Genetically Engineered (GE) Animals FDA and USDA Regulation of GE Animals Livestock Cloning/Product Labeling H.R. 3161 S. 1859 H.R. 2764 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855
Drug Safety H.R. 3580; H.R. 2900 S. 1082 Livestock Cloning/Product Labeling H.R. 3161 S. 1859 H.R. 2764 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 Drug Importation H.R. 3161 S. 1859 S. 1644 H.R. 2628 H.R. 2764 Animal Cloning Regulations Publication of FDA Draft Risk Assessment Study on Cloning of Livestock (H.R. 2419; H.R. 2764; H.R. 3161; S. 1859) Genetically Engineered (GE) Animals FDA and USDA Regulation of GE Animals Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence
Patent Reform H.R. 1908 S. 1145 Gene Patenting H.R. 977 ITC Exclusion Orders - Impact on Biotechnology Qualcomm Case CBD TRIPS Amendment Patent Disclosure Requirements PTO Proposed Regulations Continuation Rules: FR 2005-P-066 Claims Rules: FR 2005-P-067 Information Disclosure Rules: 71-FR-38808 Alternative Claims Rule: 72-FR-154 Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World Bayh-Dole Act Evaluation International Intellectual Property Enforcement Anti-counterfeiting IP Provisions in Free Trade Agreements
World Trade Organization on EU Biotech Moratorium U.S. Government Dispute Settlement Proceedings Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement China Biotechnology Regulations Mexico Biotech Regulations France Regulations of Plant Biotechnology Biosafety Protocol Implementation and Effect on Agricultural Biotechnology Possible U.S. Government Ratification U.S. Government Positions at Biosafety Protocol Meetings International Intellectual Property Enforcement Anti-counterfeiting ITC Exclusion Orders - Impact on Biotechnology Qualcomm Case CBD TRIPS Amendment Patent Disclosure Requirments Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World Farm Subsidies in Trade H.R. 2720 Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Restrictions on Importation of Plant Products/Lacey Act Amendments H.R. 1497 Drug Importation H.R. 3161 S. 1859 S. 1644 H.R. 2628 H.R. 2764
Medicaid Rebates H.R. 3162; H.R. 2764 S. 2499 Pharmaceutical Anti-Counterfeiting H.R. 3580; H.R. 2900 S. 1082 340B of the Public Health Service Act/Drug Prices for Covered Entitites Coverage of Different Entities S. 2499 Comparative Effectiveness Program Initiatives S. 2499 H.R. 3162; H.R. 2764; H.R. 976; H.R. 3963 Drug Importation H.R. 3161 S. 1859 S. 1644 H.R. 2628 H.R. 2764 Vaccines and Distribution/Shortage Issues H.R. 4991 S. 2456 Vaccines and Medicare Part B/Part D H.R. 4992
Biobased Products Tax Credits H.R. 2419 H.R. 3586 Biofuels Tax Credits H.R. 2776 H.R. 2419 H.R. 6 S. 2242 H.R. 5890 Biofuels Funding H.R. 3161 S. 1859 H.R. 2641 S. 1751 H.R. 2764 H.R. 2419 Biorefinery Loan Guarantees H.R. 3221 S. 1321 Renewable Fuels Standard H.R. 6 H.R. 322 S. 1321 Biorefinery Solicitation Demonstration Projects for Feedstock Culture and Collection H.R. 2419
Funding for National Institutes of Health H.R. 3043 S. 1710 H.R. 2764 Biofuels Funding H.R. 3161 S. 1859 H.R. 2641 S. 1751 H.R. 2419 H.R. 2764 Funding for Food and Drug Administration (FDA) (Critical Path Initiative; Human Drug Review) H.R. 3161 S. 1859 H.R. 2764 Funding for State Children's Health Insurance Program S. 2086; S. 1893; S. 2499 H.R. 3162; H.R. 3963; H.R. 976 Funding for the Biomedical Advanced Research & Development Authority (BARDA) H.R. 3043 S. 1710 H.R. 2764 Funding for Pandemic Influenza H.R. 3043 S. 1710 H.R. 2764 Funding for Department of Agriculture (Biotechnology Regulatory Services) H.R. 3043 S. 1859 H.R. 2764
Animal Cloning Regulations Publication of FDA Draft Risk Assessment Study on Cloning of Livestock (H.R. 2419; H.R. 2764; H.R. 3161; S. 1859) Livestock Cloning/Product Labeling H.R. 3161 S. 1859 H.R. 2764 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 Genetically Engineered (GE) Animals FDA and USDA Regulations of GE Animals
Farm Subsidies in Trade H.R. 2720 Biobased Products Tax Credits H.R. 2419 H.R. 3586 Biofuels Tax Credit H.R. 2776 H.R. 2419 H.R. 6 S. 2242 H.R. 5890 Renewable Fuels Standard H.R. 6 H.R. 322 S. 1321 Biofuels Funding H.R. 3161 S. 1859 H.R. 2641 S. 1751 H.R. 2764 H.R. 2419 Biorefinery Solicitation Biorefinery Loan Guarantees H.R. 3221 S. 1321 Foreign Agricultural Biotechnology Laws and Regulations U.S. Korea Free Trade Agreement China Biotechnology Regulations Mexico Biotech Regulations France Regulations of Plant Biotechnology Restrictions on Importation of Plant Products/Lacey Act Amendments H.R. 2419 2007 Farm Bill (H.R. 2419) USDA Research and Regulatory Requirements for Ag-Biotech Federal Preemption Study Regarding Cloning of Livestock Study of Competitiveness of Ag-Biotech Industry Biobased Procurement -- USDA Program Demonstration Project for Feedstock Culture and Collection Biofuels Funding Importation of Plant Products Funding for Department of Agriculture (Biotechnology Regulatory Services) H.R. 3043 S. 1859 H.R. 2764 Genetically Engineered (GE) Animals FDA and USDA Regulation of GE Animals Livestock Cloning/Product Labeling H.R. 3161 S. 1859 H.R. 2764 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 Animal Cloning Regulations Publication of FDA Draft Risk Assessment Study on Cloning of Livestock (H.R. 2419; H.R. 2764; H.R. 3161; S. 1859) World Trade Organization on EU Biotech Moratorium U.S. Government Dispute Settlement Proceedings USDA Agriculture Biotechnology Regulations & Policies Release of Programmatic Environmental Impact Statement (EIS) Biotechnology Crop Stewardship Proposed Legislation Biosafety Protocol Implementation and Effect on Agricultural Biotechnology Possible U.S. Government Ratification U.S. Government Positions at Biosafety Protocol Meetings Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence EPA Regulation of Plant Agricultural Biotechnology Release of Draft Proposed Rule on Reporting Requirements for Plant Agricultural Biotechnology
Infectious Disease Tax Credit S. 2351 R&D Tax Credit (H.R. 2764) Extension Permanence Alternatives Biobased Products Tax Credits H.R. 2419 H.R. 3586 Biofuels Tax Credits H.R. 2776 H.R. 2419 H.R. 6 S. 2242 H.R. 5890 Carried Interest Tax Treatment Biotech Capital Formation Tax Incentives/Net Operating Losses H.R. 3264: American Life Sciences Competitiveness Act of 2007
Sarbanes-Oxley Reform Section 404 SEC and PCAOB Guidance on Auditing Standard (AS-5) Revenue Recognition on Collaborative Agreements SEC Guidance Carried Interest Tax Treatment Biotech Capital Formation Tax Incentives/Net Operating Losses H.R. 3264: American Life Sciences Competitiveness Act of 2007 Convertible Debt Accounting FASB Proposed Guidance
Biobased Products Tax Credits H.R. 2419 H.R. 3586 Biofuels Tax Credits H.R. 2776 H.R. 2419 H.R. 6 S. 2242 H.R. 5890 Biorefinery Loan Guarantees H.R. 3221 S. 1321 Renewable Fuels Standard H.R. 6 H.R. 322 S. 1321 Biofuels Funding H.R. 3161 S. 1859 H.R. 2641 S. 1751 H.R. 2764 H.R. 2419 Biorefinery Solicitation Demonstration Projects for Feedstock Culture and Collection H.R. 2419
Drug Safety H.R. 3580; H.R. 2900 S. 1082 Medicaid Rebates H.R. 3162 H.R. 2764 S. 2499 Comparative Effectiveness Program Initiatives H.R. 3162; H.R. 2764; H.R. 976; H.R. 3963 S. 2499 Stem Cell Research Drug Importation H.R. 3161 S. 1859 S. 1644 H.R. 2628 H.R. 2764 Funding for Food and Drug Administration (Critical Path Initiative; Human Drug Review) H.R. 3161 S. 1859 H.R. 2764 340B of the Public Health Service Act/Drug Prices for Covered Entitites Coverage of Different Entities S. 2499 FDA Regulatory Processes for First-Time Filers Food & Drug Administration Amendments Act/Food & Drug Administration Revitalization Act (H.R. 3580; H.R. 2900; S. 1082) User Fees/FDA Waivers for Small Businesses Risk Management Plans and Post-market Authorities Clinical Trial Registry and Results Databases Preemption Pharmaceutical Anti-Counterfeiting Priority Review Vouchers for Approved New Tropical Disease Therapies Civil Monetary Penalties FDA Advisory Panels/Conflict of Interest Possible Follow-on Biologics Amendments Follow-on Biologics H.R. 1038 H.R. 1956 S. 1695 S. 623 Presciption Drug User Fees H.R. 3580; H.R. 2900 S. 1082 Vaccines for Children Program H.R. 4990 Vaccines for Uninsured Adults H.R. 4993 National Vaccine Immunization Rates National Vaccine Program Office Working Paper on Adolescent Immunization Influenza Immunization Physician Quality Reporting Inititiative Vaccine Financing National Vaccine Program Office Draft White Paper on Vaccine Financing Vaccines and Medicare Part B/Part D H.R. 4992 Vaccines and Distribution/Shortage Issues H.R. 4991 S. 2456 Funding for Pandemic Influenza H.R. 3043 S. 1710 H.R. 2764 BARDA and Project BioShield HHS Implementation Plans Funding (H.R. 3043; S. 1710; H.R. 2764) Emerging Diseases Regulatory Processes Emergency Use Authorization Genetic Testing Regulatory Oversight Infectious Disease Research Tax Credit S. 2351 Funding for State Children's Health Insurance Program S. 2086; S. 1893; S. 2499 H.R. 3162; H.R. 3963; H.R. 976 Pharmaceutical Anti-Counterfeiting H.R. 3580; H.R. 2900 S. 1082 Erythropiesis Stimulating Agents CMS National Coverage Decision
Vaccines and Distribution/Shortage Issues H.R. 4991 S. 2456 BARDA and Project BioShield HHS Implementation Plans Funding (H.R. 3043; S.1710; H.R. 2764) Funding for Pandemic Influenza H.R. 3043 S. 1710 H.R. 2764
Funding for National Institutes of Health H.R. 3043 S. 1710 H.R. 2764 BARDA and Project BioShield HHS Implementation Plans Funding (H.R. 3043; S.1710; H.R. 2764) Funding for Pandemic Influenza H.R. 3043 S. 1710 H.R. 2764 Critical Path Inititive H.R. 3161 S. 1859 Stem Cell Research Genetic Testing Regulatory Oversight Infectious Disease Reserach Tax Credit S. 2351 Comparative Effectiveness Program Initiatives S. 2499 H.R. 3162; H.R. 2764; H.R. 976; H.R. 3963
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), UNDETERMINED, White House Office
Patent Reform H.R. 1908 S. 1145
Biobased Products Tax Credits H.R. 2419 H.R. 3586
Infectious Disease Tax Credit S. 2351
World Trade Organization on EU Biotech Moratorium U.S. Government Dispute Settlement Proceedings
Stem Cell Research
Farm Subsidies in Trade H.R. 2720
Drug Safety H.R. 3580; H.R. 2900 S. 1082
Medicaid Rebates H.R. 3162; H.R. 2764 S. 2499
Funding for National Institutes of Health H.R. 3043 S. 1710 H.R. 2764
Animal Cloning Regulations Publication of FDA Draft Risk Assessment Study on Cloning of Livestock (H.R. 2419; H.R. 2764; H.R. 3161; S. 1859)
Drug Safety H.R. 3580; H.R. 2900 S. 1082
Vaccines and Distribution/Shortage Issues H.R. 4991 S. 2456
Funding for National Institutes of Health H.R. 3043 S. 1710 H.R. 2764
Adventitious Presence U.S. Government Policy Position for Codex Guidelines on Adventitious Presence
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office