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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
Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---H.R. 10: Financial Choice Act Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 4015: Corporate Governance Reform and Transparency Act of 2017 ---H.R. 10: Financial Choice Act Sarbanes Oxley Section 404 (b) ---H.R. 1645/S. 2126: Fostering Innovation Act Short Selling Transparency Small Business Intellectual Property Training ---H.R. 2655: Small Business Innovation Protection Act XBRL Exemption for Small Public Companies ---H.R. 5054: Small Company Disclosure Simplification Act ---H.R. 10: Financial Choice Act
Fostering Innovation Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
2018 · first_quarter · Q1
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act ---H.R. 1892: Bipartisan Budget Act of 2018 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 Corporate Tax Reform Orphan Drug Issues ---Tax Credit ---Technical Amendments Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149/S. 1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Research & Development Tax Credit Reforms ---Refundable R&D Credit Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---H.R. 4993: Vaccine Access Improvement Act
Source: Senate LDA
Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---H.R. 10: Financial Choice Act Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 4015: Corporate Governance Reform and Transparency Act of 2017 ---H.R. 10: Financial Choice Act Sarbanes Oxley Section 404 (b) ---H.R. 1645/S. 2126: Fostering Innovation Act Short Selling Transparency Small Business Intellectual Property Training ---H.R. 2655: Small Business Innovation Protection Act XBRL Exemption for Small Public Companies ---H.R. 5054: Small Company Disclosure Simplification Act ---H.R. 10: Financial Choice Act
Bipartisan Budget Act of 2018
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act ---H.R. 1892: Bipartisan Budget Act of 2018 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 Corporate Tax Reform Orphan Drug Issues ---Tax Credit ---Technical Amendments Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149/S. 1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Research & Development Tax Credit Reforms ---Refundable R&D Credit Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---H.R. 4993: Vaccine Access Improvement Act
PARTNER Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act ---H.R. 1892: Bipartisan Budget Act of 2018 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 Corporate Tax Reform Orphan Drug Issues ---Tax Credit ---Technical Amendments Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149/S. 1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Research & Development Tax Credit Reforms ---Refundable R&D Credit Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---H.R. 4993: Vaccine Access Improvement Act
Small Business Innovation Protection Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---H.R. 10: Financial Choice Act Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 4015: Corporate Governance Reform and Transparency Act of 2017 ---H.R. 10: Financial Choice Act Sarbanes Oxley Section 404 (b) ---H.R. 1645/S. 2126: Fostering Innovation Act Short Selling Transparency Small Business Intellectual Property Training ---H.R. 2655: Small Business Innovation Protection Act XBRL Exemption for Small Public Companies ---H.R. 5054: Small Company Disclosure Simplification Act ---H.R. 10: Financial Choice Act
Renewable Chemicals Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act ---H.R. 1892: Bipartisan Budget Act of 2018 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 Corporate Tax Reform Orphan Drug Issues ---Tax Credit ---Technical Amendments Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149/S. 1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Research & Development Tax Credit Reforms ---Refundable R&D Credit Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---H.R. 4993: Vaccine Access Improvement Act
Corporate Governance Reform and Transparency Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---H.R. 10: Financial Choice Act Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 4015: Corporate Governance Reform and Transparency Act of 2017 ---H.R. 10: Financial Choice Act Sarbanes Oxley Section 404 (b) ---H.R. 1645/S. 2126: Fostering Innovation Act Short Selling Transparency Small Business Intellectual Property Training ---H.R. 2655: Small Business Innovation Protection Act XBRL Exemption for Small Public Companies ---H.R. 5054: Small Company Disclosure Simplification Act ---H.R. 10: Financial Choice Act
Master Limited Partnerships Parity Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act ---H.R. 1892: Bipartisan Budget Act of 2018 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 Corporate Tax Reform Orphan Drug Issues ---Tax Credit ---Technical Amendments Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149/S. 1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Research & Development Tax Credit Reforms ---Refundable R&D Credit Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---H.R. 4993: Vaccine Access Improvement Act
Vaccine Access Improvement Act of 2018
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act ---H.R. 1892: Bipartisan Budget Act of 2018 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 Corporate Tax Reform Orphan Drug Issues ---Tax Credit ---Technical Amendments Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149/S. 1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Research & Development Tax Credit Reforms ---Refundable R&D Credit Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---H.R. 4993: Vaccine Access Improvement Act
Small Company Disclosure Simplification Act of 2018
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---H.R. 10: Financial Choice Act Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 4015: Corporate Governance Reform and Transparency Act of 2017 ---H.R. 10: Financial Choice Act Sarbanes Oxley Section 404 (b) ---H.R. 1645/S. 2126: Fostering Innovation Act Short Selling Transparency Small Business Intellectual Property Training ---H.R. 2655: Small Business Innovation Protection Act XBRL Exemption for Small Public Companies ---H.R. 5054: Small Company Disclosure Simplification Act ---H.R. 10: Financial Choice Act
Renewable Chemicals Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act ---H.R. 1892: Bipartisan Budget Act of 2018 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 Corporate Tax Reform Orphan Drug Issues ---Tax Credit ---Technical Amendments Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149/S. 1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Research & Development Tax Credit Reforms ---Refundable R&D Credit Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---H.R. 4993: Vaccine Access Improvement Act
Master Limited Partnerships Parity Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act ---H.R. 1892: Bipartisan Budget Act of 2018 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 Corporate Tax Reform Orphan Drug Issues ---Tax Credit ---Technical Amendments Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149/S. 1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Research & Development Tax Credit Reforms ---Refundable R&D Credit Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---H.R. 4993: Vaccine Access Improvement Act
Fostering Innovation Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---H.R. 10: Financial Choice Act Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 4015: Corporate Governance Reform and Transparency Act of 2017 ---H.R. 10: Financial Choice Act Sarbanes Oxley Section 404 (b) ---H.R. 1645/S. 2126: Fostering Innovation Act Short Selling Transparency Small Business Intellectual Property Training ---H.R. 2655: Small Business Innovation Protection Act XBRL Exemption for Small Public Companies ---H.R. 5054: Small Company Disclosure Simplification Act ---H.R. 10: Financial Choice Act
An Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
An Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---Sen. Grassley Amendment #11 to H.R. 1: Tax Cuts & Jobs Act ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act 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 Corporate Tax Reform ---H.R. 1: Tax Cuts & Jobs Act Orphan Drug Issues ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149/S. 1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Research & Development Tax Credit Reforms ---Extension ---Permanency ---Refundable R&D Credit ---H.R. 1: Tax Cuts & Jobs Act
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 ---PCAOB Audit Cost Increases ---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 Sarbanes Oxley Section 404 (b) ---H.R. 10: Financial CHOICE Act ---H.R. 1645: Fostering Innovation Act ---PCAOB Audit Cost Increases ---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)
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
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
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 ---PCAOB Audit Cost Increases ---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 Sarbanes Oxley Section 404 (b) ---H.R. 10: Financial CHOICE Act ---H.R. 1645: Fostering Innovation Act ---PCAOB Audit Cost Increases ---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 ---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)
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 ---PCAOB Audit Cost Increases ---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 Sarbanes Oxley Section 404 (b) ---H.R. 10: Financial CHOICE Act ---H.R. 1645: Fostering Innovation Act ---PCAOB Audit Cost Increases ---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 ---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)
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
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 ---PCAOB Audit Cost Increases ---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 Sarbanes Oxley Section 404 (b) ---H.R. 10: Financial CHOICE Act ---H.R. 1645: Fostering Innovation Act ---PCAOB Audit Cost Increases ---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)
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
Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions Proxy Advisory Services ---H.R. 4015: Corporate Governance Reform and Transparency Act of 2017 ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---H.R. 1645/S. 2126: Fostering Innovation Act ---Small Issuer Exemption Short Selling Transparency XBRL Exemption for Small Public Companies ---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)
Medical Product Communications Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
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) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
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
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
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
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 Corporate Tax Reform Orphan Drug Issues ---Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149: Renewable Chemicals Act of 2017 ---The Master Limited Partnership Act (Sen. Coons' Discussion Draft) ---The Renewable Chemicals Act (Sen. Coons' Discussion Draft) Research & Development Tax Credit Reforms ---Extension ---Permanency ---Refundable R&D Credit Treatment of Financial Interests as Stock or Indebtedness ---Section 385 Proposed Regulations
Pharmaceutical Information Exchange Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
CREATES Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
CREATES Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
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 Corporate Tax Reform Orphan Drug Issues ---Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149: Renewable Chemicals Act of 2017 ---The Master Limited Partnership Act (Sen. Coons' Discussion Draft) ---The Renewable Chemicals Act (Sen. Coons' Discussion Draft) Research & Development Tax Credit Reforms ---Extension ---Permanency ---Refundable R&D Credit Treatment of Financial Interests as Stock or Indebtedness ---Section 385 Proposed Regulations
PARTNER Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---Sen. Grassley Amendment #11 to H.R. 1: Tax Cuts & Jobs Act ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act 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 Corporate Tax Reform ---H.R. 1: Tax Cuts & Jobs Act Orphan Drug Issues ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149/S. 1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Research & Development Tax Credit Reforms ---Extension ---Permanency ---Refundable R&D Credit ---H.R. 1: Tax Cuts & Jobs Act
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
Medicare Prescription Drug Price Negotiation Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
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) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
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) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
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) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
Stop Price Gouging Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
Stop Price Gouging Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
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
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 Corporate Tax Reform Orphan Drug Issues ---Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149: Renewable Chemicals Act of 2017 ---The Master Limited Partnership Act (Sen. Coons' Discussion Draft) ---The Renewable Chemicals Act (Sen. Coons' Discussion Draft) Research & Development Tax Credit Reforms ---Extension ---Permanency ---Refundable R&D Credit Treatment of Financial Interests as Stock or Indebtedness ---Section 385 Proposed Regulations
Renewable Chemicals Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---Sen. Grassley Amendment #11 to H.R. 1: Tax Cuts & Jobs Act ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act 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 Corporate Tax Reform ---H.R. 1: Tax Cuts & Jobs Act Orphan Drug Issues ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149/S. 1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Research & Development Tax Credit Reforms ---Extension ---Permanency ---Refundable R&D Credit ---H.R. 1: Tax Cuts & Jobs Act
Make America Secure Appropriations Act, 2018
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
Make America Secure Appropriations Act, 2018
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2018
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2018
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2018
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2018
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
HEALTHY KIDS Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
Corporate Governance Reform and Transparency Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions Proxy Advisory Services ---H.R. 4015: Corporate Governance Reform and Transparency Act of 2017 ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---H.R. 1645/S. 2126: Fostering Innovation Act ---Small Issuer Exemption Short Selling Transparency XBRL Exemption for Small Public Companies ---Small Company Disclosure Simplification Act (House Discussion Draft)
Master Limited Partnerships Parity Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---Sen. Grassley Amendment #11 to H.R. 1: Tax Cuts & Jobs Act ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act 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 Corporate Tax Reform ---H.R. 1: Tax Cuts & Jobs Act Orphan Drug Issues ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149/S. 1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Research & Development Tax Credit Reforms ---Extension ---Permanency ---Refundable R&D Credit ---H.R. 1: Tax Cuts & Jobs Act
Medicare Drug Price Negotiation Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
340B PAUSE Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
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) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
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) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
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)
Protecting Seniors Access to Medicare Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
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) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
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
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) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
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) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
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) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
Stop Price Gouging Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
Stop Price Gouging Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2018
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2018
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2018
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2018
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
Renewable Chemicals Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---Sen. Grassley Amendment #11 to H.R. 1: Tax Cuts & Jobs Act ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act 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 Corporate Tax Reform ---H.R. 1: Tax Cuts & Jobs Act Orphan Drug Issues ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149/S. 1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Research & Development Tax Credit Reforms ---Extension ---Permanency ---Refundable R&D Credit ---H.R. 1: Tax Cuts & Jobs Act
Master Limited Partnerships Parity Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---Sen. Grassley Amendment #11 to H.R. 1: Tax Cuts & Jobs Act ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act 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 Corporate Tax Reform ---H.R. 1: Tax Cuts & Jobs Act Orphan Drug Issues ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149/S. 1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Research & Development Tax Credit Reforms ---Extension ---Permanency ---Refundable R&D Credit ---H.R. 1: Tax Cuts & Jobs Act
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
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) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
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) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
Fostering Innovation Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions Proxy Advisory Services ---H.R. 4015: Corporate Governance Reform and Transparency Act of 2017 ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---H.R. 1645/S. 2126: Fostering Innovation Act ---Small Issuer Exemption Short Selling Transparency XBRL Exemption for Small Public Companies ---Small Company Disclosure Simplification Act (House Discussion Draft)
Protecting Seniors' Access to Medicare Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
Protecting Seniors' Access to Medicare Act of 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
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 ---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 ---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 ---PCAOB Audit Cost Increases ---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 Sarbanes Oxley Section 404 (b) ---H.R. 10: Financial CHOICE Act ---H.R. 1645: Fostering Innovation Act ---PCAOB Audit Cost Increases ---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)
RACE for Children Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
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) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
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) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
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 ---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)
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 ---PCAOB Audit Cost Increases ---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 Sarbanes Oxley Section 404 (b) ---H.R. 10: Financial CHOICE Act ---H.R. 1645: Fostering Innovation Act ---PCAOB Audit Cost Increases ---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)
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)
Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions ---H.R. 10: Financial Choice Act Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 4015: Corporate Governance Reform and Transparency Act of 2017 ---H.R. 10: Financial Choice Act Sarbanes Oxley Section 404 (b) ---H.R. 1645/S. 2126: Fostering Innovation Act Short Selling Transparency Small Business Intellectual Property Training ---H.R. 2655: Small Business Innovation Protection Act XBRL Exemption for Small Public Companies ---H.R. 5054: Small Company Disclosure Simplification Act ---H.R. 10: Financial Choice 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), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR), White House Office
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2017 · fourth_quarter · Q4
Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions Proxy Advisory Services ---H.R. 4015: Corporate Governance Reform and Transparency Act of 2017 ---Impact of Policies on Small Public Companies Sarbanes Oxley Section 404 (b) ---H.R. 1645/S. 2126: Fostering Innovation Act ---Small Issuer Exemption Short Selling Transparency XBRL Exemption for Small Public Companies ---Small Company Disclosure Simplification Act (House Discussion Draft)
Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension ---Sen. Grassley Amendment #11 to H.R. 1: Tax Cuts & Jobs Act ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act 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 Corporate Tax Reform ---H.R. 1: Tax Cuts & Jobs Act Orphan Drug Issues ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149/S. 1980: Renewable Chemicals Act of 2017 ---H.R. 4118/S. 2005: Master Limited Partnership Parity Act Research & Development Tax Credit Reforms ---Extension ---Permanency ---Refundable R&D Credit ---H.R. 1: Tax Cuts & Jobs Act
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 4710: 340B Pause Act Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) Biosimilars ---S. 974/H.R. 2212: CREATES Act of 2017 ---Access to Samples Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---Biosimilar User Fee Amendments (BSUFA) II Implementation Drug Importation ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: 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 ---S.Con.Res. 25: An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2018 and setting forth the appropriate budgetary levels for fiscal years 2019 through 2027 Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications ---H.R. 1703: The Medical Products Communications Act ---H.R. 2026: Pharmaceutical Information Exchange Act Funding for Antimicrobial Resistance Programs ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: 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 Independent Payment Advisory Board Repeal ---H.R. 849/S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---H.R. 1: Tax Cuts & Jobs Act 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---H.R. 242: Medicare Prescription Drug Price Negotiation Act ---H.R. 4138: Medicare Drug Price Negotiation Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR), White House Office
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2017 · third_quarter · Q3
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 Corporate Tax Reform Orphan Drug Issues ---Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---Expansion of Master Limited Partnerships to Renewable Chemicals ---Investment Tax Credit ---Production Tax Credit ---HR 3149: Renewable Chemicals Act of 2017 ---The Master Limited Partnership Act (Sen. Coons' Discussion Draft) ---The Renewable Chemicals Act (Sen. Coons' Discussion Draft) Research & Development Tax Credit Reforms ---Extension ---Permanency ---Refundable R&D Credit Treatment of Financial Interests as Stock or Indebtedness ---Section 385 Proposed Regulations
340B Drug Discount Program ---340B Program Reforms (Rep. C. Collins Discussion Draft) ---Program Implementation & Oversight ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Affordable Care Act - Repeal and Replace ---The Better Care Reconciliation Act of 2017 (Senate Discussion Draft) Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Asia Pacific Economic Cooperation Forum ---Biologics Regulations Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 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 ---Reauthorization of the Prescription Drug User Fee Act ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.204 / H.R. 878: Right to Try Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Drug Importation ---Welch Amendment to H.R. 2430: FDA Reauthorization Act of 2017 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.469: Affordable and Safe Prescription Drug Importation Act ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Drug Manufacturing, Quality & Distribution ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Pricing ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---S. 934/H.R. 2430: FDA Reauthorization Act of 2017 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 1681: A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services 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 ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for FDA ---H.R. 3268/S.1603: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for National Institutes of Health ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 3358/S.1771: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---H.R. 3354: Omnibus 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. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S. 974/H.R. 2212: CREATES Act of 2017 Independent Payment Advisory Board Repeal ---S. 260: Protecting Seniors' Access to Medicare Act Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Section 1115 Waivers North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---Regulatory Harmonization ---IP Provisions Opioid Crisis Orphan Drug Issues ---Technical Amendments ---Tax Credit ---S. 934 / H.R. 2430: FDA Reauthorization Act of 2017 ---S.456 / H.R. 1231: RACE for Children Act Reauthorization of Children's Health Insurance Program ---H.R. 3921: The HEALTHY KIDS 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 ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety
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 ---PCAOB Audit Cost Increases ---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 Sarbanes Oxley Section 404 (b) ---H.R. 10: Financial CHOICE Act ---H.R. 1645: Fostering Innovation Act ---PCAOB Audit Cost Increases ---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)
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), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE, U.S. Trade Representative (USTR), White House Office
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2017 · second_quarter · Q2
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
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
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
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2016 · second_quarter · Q2
340B Drug Pricing Program ----Implementation of Affordable Care Act ---Program Implementation & Oversight ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act Biosimilars ---Biosimilar User Fee Act Reauthorization and Implementation ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Access to Samples for Testing ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Drug Evaluation and Review ---ADAPT Act (House Discussion Draft) ---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 Drug Importation ---H.R.5054 - S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325-S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 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.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Orphan Drug Act Tax Credit Precision Medicine Initiative Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products -- --CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications 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 ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---- S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---S. 1878: Advancing Hope Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act UN High Level Commission on Access to Medicines Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---Senate Chronic Care Working Group Proposals ---Vaccine Injury Compensation Program ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Vaccines and Infectious Diseases - General ---H.R. 3299: Strengthening Public Health Emergency Response Act ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Combating Antibiotic-Resistant Bacteria (CARB) Initiative Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Vial and Dose Size Gene Editing Technologies ---S.3040-H.R.5325: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Government Price Reporting ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2016 · first_quarter · Q1
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  
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
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
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)
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
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2012 · fourth_quarter · Q4
Funding for National Institutes of Health National Center for Advancing Translational Sciences (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Vaccine Access/Financing Federal Response to the Rising Rates of Autism 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 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act of 2010 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 Drug Safety and Review E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discuss Draft) Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act of 2012 Pharmacy Compounding 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 Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act of 2010 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 S 1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 HHS Countermeasures Review TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Regulatory Transparency Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act Medicaid Rebates
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
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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
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
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)
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.
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
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
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)
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
Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014Biosimilars Colombia Biologics Regulations Interchangeability and Pharmacy Substitution Naming Implementation of Affordable Care Act 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 Vaccine Access/Financing Vaccine Injury Compensation Program Adult Immunization (Senate Discussion Draft) 340B Drug Pricing Program Program Implementation & Oversight Implementation of Affordable Care Act S. 1284: Department of Labor, HHS, Education and Related Agencies Appropriations Act for FY 2014 Funding for FDA H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Independent Payment Advisory Board 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: The Bipartisan Budget Act of 2013 Biodefense Research, Development and Procurement Issues Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Senate Finance Committee Discussion Draft H.R. 1416: Cancer Patient Protection Act of 2013 Sequestration of PDUFA Fees H.J. Res. 59: The Bipartisan Budget Act of 2013 H.R. 2410/S. 1244: Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2014 HR 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 Implementation of S. 365: Budget Control Act S. 1413: FDA User Fee Protection Act Transatlantic Trade and Investment Partnership Regulatory Harmonization Intellectual Property Issues Drug Evaluation and Review Special Medical Use/Limited Population Drug H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Implementation of FDA Safety and Innovation Act Orphan Drug Act Tax CreditDrug Manufacturing, Quality & Distribution Supply Chain Integrity Pharmacy Compounding & Oversight Drug Shortages H.R. 3204: The Drug Quality & Security Act Clinical Trial Data Sharing and Disclosure EU Policies TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Coordination of Federal Biotechnology Research
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
Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014Biosimilars Colombia Biologics Regulations Interchangeability and Pharmacy Substitution Naming Implementation of Affordable Care Act 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 Vaccine Access/Financing Vaccine Injury Compensation Program Adult Immunization (Senate Discussion Draft) 340B Drug Pricing Program Program Implementation & Oversight Implementation of Affordable Care Act S. 1284: Department of Labor, HHS, Education and Related Agencies Appropriations Act for FY 2014 Funding for FDA H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Independent Payment Advisory Board 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: The Bipartisan Budget Act of 2013 Biodefense Research, Development and Procurement Issues Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Senate Finance Committee Discussion Draft H.R. 1416: Cancer Patient Protection Act of 2013 Sequestration of PDUFA Fees H.J. Res. 59: The Bipartisan Budget Act of 2013 H.R. 2410/S. 1244: Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2014 HR 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 Implementation of S. 365: Budget Control Act S. 1413: FDA User Fee Protection Act Transatlantic Trade and Investment Partnership Regulatory Harmonization Intellectual Property Issues Drug Evaluation and Review Special Medical Use/Limited Population Drug H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Implementation of FDA Safety and Innovation Act Orphan Drug Act Tax CreditDrug Manufacturing, Quality & Distribution Supply Chain Integrity Pharmacy Compounding & Oversight Drug Shortages H.R. 3204: The Drug Quality & Security Act Clinical Trial Data Sharing and Disclosure EU Policies TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Coordination of Federal Biotechnology Research
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
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
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
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