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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.
Consolidated Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
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
2016 · third_quarter · Q3
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
Source: Senate LDA
Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017 and Zika Response and Preparedness Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act 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
Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017 and Zika Response and Preparedness Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act 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 Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, 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 Gene Editing Technologies ---S.3040-H.R.5325: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative Senate Innovation for Healthier Americans ---Longitudinal Study of Chronic Diseases Combating Antibiotic-Resistant Bacteria (CARB) Initiative
Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017 and Zika Response and Preparedness Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017 and Zika Response and Preparedness Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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 Biofuels ---H.R.5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biomass Crop Assistance Program ---H.R.5054-S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 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 Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054 -S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R.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 Renewable Chemicals/Bio-based Products ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Funding for the USDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Energy Basic Research Funding ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017
Strengthening Public Health Emergency Response Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
Strengthening Public Health Emergency Response Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
Strengthening Public Health Emergency Response Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Senate Innovation for Healthier Americans ---Longitudinal Study of Chronic Diseases Precision Medicine Initiative
Strengthening Public Health Emergency Response Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act 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
Strengthening Public Health Emergency Response Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act 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 Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, 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 Gene Editing Technologies ---S.3040-H.R.5325: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative Senate Innovation for Healthier Americans ---Longitudinal Study of Chronic Diseases Combating Antibiotic-Resistant Bacteria (CARB) Initiative
Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Coding --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Patent Certification --Brazil Biologics Regulations Funding for National Institutes of Health --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for Centers for Disease Control and Prevention Vaccine Programs --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 340B Drug Pricing Program --Implementation of Affordable Care Act --Program Implementation & Oversight --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Drug Importation --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Biodefense Research, Development and Procurement Issues (Nonfunding) Reimbursement for Innovative Products --Medicare Part B Physician-Administered Products --Medicare Part D Prescription Drug Program: ----CMS Proposed Rule on Protected Classes --Value-based Contracting and Communications Drug Evaluation and Review --Compassionate Use/Expanded Access --FDA Proposed Rule on Changes to Drug Labeling --Implementation of the FDA Safety and Innovation Act --Reauthorization of the Prescription Drug User Fee Act --Special Medical Use/Limited Population Drug ---- ADAPT Act (House Discussion Draft) Senate Innovation for Healthier Americans --Biomarkers and Regulatory Science Improvements --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives ----S. 195: PATH Act --Communication with Healthcare Professionals and Payors --Priority Review Voucher Programs Priority Review of Generic Drugs ----S. 2615: Increasing Competition in Pharmaceuticals Act Vaccines and Infectious Diseases - General Government Price Reporting --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Gene Editing Technologies --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act Drug Manufacturing, Quality & Distribution --Supply Chain Integrity and Traceability Affordable Care Act Implementation --Third Party Support of Patient Premiums and Cost-Sharing Obligations Combating Antibiotic-Resistant Bacteria (CARB) Initiative Vaccine Access/Financing --Adult Immunization (Senate Discussion Draft) --Implementation of Affordable Care Act --Senate Chronic Care Working Group Proposals --Vaccine Injury Compensation Program TransPacific Partnership --Data and Intellectual Property Protection for Pharmaceuticals --Reimbursement Transparency Orphan Drug Act Tax Credit UN Commission on Access to Medicines
Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
REGROW Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
REGROW Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Senate Innovation for Healthier Americans ---Longitudinal Study of Chronic Diseases Precision Medicine Initiative
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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 Biofuels ---H.R.5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biomass Crop Assistance Program ---H.R.5054-S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 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 Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054 -S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R.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 Renewable Chemicals/Bio-based Products ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Funding for the USDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Energy Basic Research Funding ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
Energy and Water Development and Related Agencies Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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 Biofuels ---H.R.5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biomass Crop Assistance Program ---H.R.5054-S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 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 Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054 -S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R.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 Renewable Chemicals/Bio-based Products ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Funding for the USDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Energy Basic Research Funding ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017
To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
Department of Defense Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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 Biofuels ---H.R.5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biomass Crop Assistance Program ---H.R.5054-S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 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 Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054 -S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R.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 Renewable Chemicals/Bio-based Products ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Funding for the USDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Energy Basic Research Funding ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017
Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017, and Zika Response and Preparedness Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Senate Innovation for Healthier Americans ---Longitudinal Study of Chronic Diseases Precision Medicine Initiative
Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017, and Zika Response and Preparedness Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017, and Zika Response and Preparedness Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act 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
Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017, and Zika Response and Preparedness Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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 Biofuels ---H.R.5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biomass Crop Assistance Program ---H.R.5054-S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 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 Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054 -S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R.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 Renewable Chemicals/Bio-based Products ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Funding for the USDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Energy Basic Research Funding ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017
Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017, and Zika Response and Preparedness Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017, and Zika Response and Preparedness Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act 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 Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, 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 Gene Editing Technologies ---S.3040-H.R.5325: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative Senate Innovation for Healthier Americans ---Longitudinal Study of Chronic Diseases Combating Antibiotic-Resistant Bacteria (CARB) Initiative
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Senate Innovation for Healthier Americans ---Longitudinal Study of Chronic Diseases Precision Medicine Initiative
Advancing Hope Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
Advancing Hope Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
401(Kids) Education Savings Account Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Coding --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Patent Certification --Brazil Biologics Regulations Funding for National Institutes of Health --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for Centers for Disease Control and Prevention Vaccine Programs --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 340B Drug Pricing Program --Implementation of Affordable Care Act --Program Implementation & Oversight --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Drug Importation --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Biodefense Research, Development and Procurement Issues (Nonfunding) Reimbursement for Innovative Products --Medicare Part B Physician-Administered Products --Medicare Part D Prescription Drug Program: ----CMS Proposed Rule on Protected Classes --Value-based Contracting and Communications Drug Evaluation and Review --Compassionate Use/Expanded Access --FDA Proposed Rule on Changes to Drug Labeling --Implementation of the FDA Safety and Innovation Act --Reauthorization of the Prescription Drug User Fee Act --Special Medical Use/Limited Population Drug ---- ADAPT Act (House Discussion Draft) Senate Innovation for Healthier Americans --Biomarkers and Regulatory Science Improvements --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives ----S. 195: PATH Act --Communication with Healthcare Professionals and Payors --Priority Review Voucher Programs Priority Review of Generic Drugs ----S. 2615: Increasing Competition in Pharmaceuticals Act Vaccines and Infectious Diseases - General Government Price Reporting --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Gene Editing Technologies --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act Drug Manufacturing, Quality & Distribution --Supply Chain Integrity and Traceability Affordable Care Act Implementation --Third Party Support of Patient Premiums and Cost-Sharing Obligations Combating Antibiotic-Resistant Bacteria (CARB) Initiative Vaccine Access/Financing --Adult Immunization (Senate Discussion Draft) --Implementation of Affordable Care Act --Senate Chronic Care Working Group Proposals --Vaccine Injury Compensation Program TransPacific Partnership --Data and Intellectual Property Protection for Pharmaceuticals --Reimbursement Transparency Orphan Drug Act Tax Credit UN Commission on Access to Medicines
401(Kids) Education Savings Account Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
401(Kids) Education Savings Account Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
Medical Countermeasure Innovation Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
Medical Countermeasure Innovation Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act 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 Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, 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 Gene Editing Technologies ---S.3040-H.R.5325: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative Senate Innovation for Healthier Americans ---Longitudinal Study of Chronic Diseases Combating Antibiotic-Resistant Bacteria (CARB) Initiative
Medical Countermeasure Innovation Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act 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
Medical Countermeasure Innovation Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
Medical Countermeasure Innovation Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Senate Innovation for Healthier Americans ---Longitudinal Study of Chronic Diseases Precision Medicine Initiative
Adding Zika Virus to the FDA Priority Review Voucher Program Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
Adding Zika Virus to the FDA Priority Review Voucher Program Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
Increasing Competition in Pharmaceuticals Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Coding --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Patent Certification --Brazil Biologics Regulations Funding for National Institutes of Health --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for Centers for Disease Control and Prevention Vaccine Programs --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 340B Drug Pricing Program --Implementation of Affordable Care Act --Program Implementation & Oversight --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Drug Importation --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Biodefense Research, Development and Procurement Issues (Nonfunding) Reimbursement for Innovative Products --Medicare Part B Physician-Administered Products --Medicare Part D Prescription Drug Program: ----CMS Proposed Rule on Protected Classes --Value-based Contracting and Communications Drug Evaluation and Review --Compassionate Use/Expanded Access --FDA Proposed Rule on Changes to Drug Labeling --Implementation of the FDA Safety and Innovation Act --Reauthorization of the Prescription Drug User Fee Act --Special Medical Use/Limited Population Drug ---- ADAPT Act (House Discussion Draft) Senate Innovation for Healthier Americans --Biomarkers and Regulatory Science Improvements --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives ----S. 195: PATH Act --Communication with Healthcare Professionals and Payors --Priority Review Voucher Programs Priority Review of Generic Drugs ----S. 2615: Increasing Competition in Pharmaceuticals Act Vaccines and Infectious Diseases - General Government Price Reporting --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Gene Editing Technologies --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act Drug Manufacturing, Quality & Distribution --Supply Chain Integrity and Traceability Affordable Care Act Implementation --Third Party Support of Patient Premiums and Cost-Sharing Obligations Combating Antibiotic-Resistant Bacteria (CARB) Initiative Vaccine Access/Financing --Adult Immunization (Senate Discussion Draft) --Implementation of Affordable Care Act --Senate Chronic Care Working Group Proposals --Vaccine Injury Compensation Program TransPacific Partnership --Data and Intellectual Property Protection for Pharmaceuticals --Reimbursement Transparency Orphan Drug Act Tax Credit UN Commission on Access to Medicines
Increasing Competition in Pharmaceuticals Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
Increasing Competition in Pharmaceuticals Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
Energy and Water Development and Related Agencies Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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 Biofuels ---H.R.5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biomass Crop Assistance Program ---H.R.5054-S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 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 Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054 -S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R.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 Renewable Chemicals/Bio-based Products ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Funding for the USDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Energy Basic Research Funding ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017
Trickett Wendler Right to Try Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
Trickett Wendler Right to Try Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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 Biofuels ---H.R.5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biomass Crop Assistance Program ---H.R.5054-S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 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 Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054 -S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R.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 Renewable Chemicals/Bio-based Products ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Funding for the USDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Energy Basic Research Funding ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Senate Innovation for Healthier Americans ---Longitudinal Study of Chronic Diseases Precision Medicine Initiative
National Biodefense Strategy Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Senate Innovation for Healthier Americans ---Longitudinal Study of Chronic Diseases Precision Medicine Initiative
National Biodefense Strategy Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
Department of Defense Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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 Biofuels ---H.R.5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biomass Crop Assistance Program ---H.R.5054-S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 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 Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054 -S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R.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 Renewable Chemicals/Bio-based Products ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Funding for the USDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Energy Basic Research Funding ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Senate Innovation for Healthier Americans ---Longitudinal Study of Chronic Diseases Precision Medicine Initiative
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act 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 Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, 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 Gene Editing Technologies ---S.3040-H.R.5325: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative Senate Innovation for Healthier Americans ---Longitudinal Study of Chronic Diseases Combating Antibiotic-Resistant Bacteria (CARB) Initiative
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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 Biofuels ---H.R.5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biomass Crop Assistance Program ---H.R.5054-S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 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 Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054 -S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R.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 Renewable Chemicals/Bio-based Products ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Funding for the USDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Energy Basic Research Funding ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act 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
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
CREATES Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
CREATES Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
Comprehensive Addiction and Recovery Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
Comprehensive Addiction and Recovery Act of 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
Drug Quality and Security Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
Compassionate Freedom of Choice Act of 2014
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorizaton and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---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 ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---Special Medical Use/Limited Population Drugs Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---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. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---Medicare Part B Physician-Administered Products ---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 ---FDA Management and Financial Accountability ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Senate Chronic Care Working Group Proposals Vaccines and Infectious Diseases - General ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---H.R. 5325: Continuing appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Orphan Drug Tax Credit Independent Payment Advisory Board UN High Level Commission on Access to Medicines ---Intellectual Property Provisions Sunshine Act Implementation Precision Medicine Initiative Affordable Care Act Implementation ---Third Party Support of Patient Premiums and Cost-Sharing Obligations
Food and Drug Administration Safety Over Sequestration Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
Food and Drug Administration Safety Over Sequestration Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -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 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 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 Biomass Crop Assistance Program -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees -H.R. 1078: FDA Safety over Sequestration Act Funding for Biofuels -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -Department of Defense Appropriations Act for FY 2016 -Department of Defense Funding of Advanced Biofuels -Energy and Water Development 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 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative - Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Food and Drug Administration Safety Over Sequestration Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Naming --Interchangeability and Pharmacy Substitution --Implementation of Affordable Care Act --Patent Certification --Reimbursement Policy Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Funding for FDA --H.R. 3049/S. 1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --HR 1078: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Drug Evaluation and Review --Implementation of the FDA Safety and Innovation Act/Prescription Drug User Fee Act Orphan Drug Act Tax Credit 21st Century Cures Initiative --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals and Payers --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculation --Reimbursement for Infusion Drugs under Medicare Part B Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015
Food and Drug Administration Safety Over Sequestration Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -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 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 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 Biomass Crop Assistance Program -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees -H.R. 1078: FDA Safety over Sequestration Act Funding for Biofuels -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -Department of Defense Appropriations Act for FY 2016 -Department of Defense Funding of Advanced Biofuels -Energy and Water Development 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 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative - Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Food and Drug Administration Safety Over Sequestration Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
Safe and Accurate Food Labeling Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Genetically Engineered (GE) Animals -FDA Approval -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Amendment on GE Salmon Labeling --Amendment to Restrict FDA Approval of GE Salmon Review and Labeling of Food Derived From Biotechnology -H.R. 1599: Safe and Accurate Food Labeling Act of 2015 -U.S. Government Policy Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification USDA/APHIS Agricultural Biotechnology Regulations -Coexistence of Production Systems -Efficient Science-Based Review of Biotech Products
Safe and Accurate Food Labeling Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Genetically Engineered (GE) Animals -FDA Approval -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Amendment on GE Salmon Labeling --Amendment to Restrict FDA Approval of GE Salmon Review and Labeling of Food Derived From Biotechnology -H.R. 1599: Safe and Accurate Food Labeling Act of 2015 -U.S. Government Policy Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification USDA/APHIS Agricultural Biotechnology Regulations -Coexistence of Production Systems -Efficient Science-Based Review of Biotech Products
Medicare Access and CHIP Reauthorization Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
Medicare Access and CHIP Reauthorization Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Naming --Interchangeability and Pharmacy Substitution --Implementation of Affordable Care Act --Patent Certification --Reimbursement Policy Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Funding for FDA --H.R. 3049/S. 1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --HR 1078: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Drug Evaluation and Review --Implementation of the FDA Safety and Innovation Act/Prescription Drug User Fee Act Orphan Drug Act Tax Credit 21st Century Cures Initiative --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals and Payers --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculation --Reimbursement for Infusion Drugs under Medicare Part B Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015
Medicare Access and CHIP Reauthorization Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
Further Continuing and Security Assistance Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for the National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014, Section 9003 Funding for Biofuels --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015
Further Continuing and Security Assistance Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016 --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016, --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Consolidated Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for National Institutes of Health ---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 (Non-funding) Senate Innovation for Healthier Americans Initiative ---Longitudinal Study of Chronic Diseases Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.2029: Consolidated Appropriations Act for FY 2016 Gene Editing Technologies ---H.R. 2029: Consolidated Appropriations Act for 2016 Precision Medicine Initiative
Consolidated Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development, and Procurement Issues (Non-funding) Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---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
Consolidated Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA ---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 Funding for FDA ---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 Funding for the National Institutes of Health ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Biofuels ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Biorefineries ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.2029: Consolidated Appropriations Act for FY 2016
Consolidated Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
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
Department of Defense Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016 --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016, --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
21st Century Care for Military and Veterans Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Biosimilar User Fee Act Implementation --Coding --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Reimbursement Policy Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development and Procurement Issues (Non-funding) TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues --Regulatory Harmonization Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 Drug Evaluation and Review --Compassionate Use/Expanded Access --Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Senate Innovation for Healthier Americans Initiative --Biomarkers and Regulatory Science Improvements --Combination Products --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Information Disclosures --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --PATH Act (Senate Discussion Draft) House 21st Century Cures Initiative --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence Vaccines and Infectious Diseases - General Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Government Price Reporting --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Gene Editing Technologies --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -----Report Language on Heritable Genetic Modification Restriction NIH Precision Medicine Initiative Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act
21st Century Care for Military and Veterans Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for the National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014, Section 9003 Funding for Biofuels --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015
21st Century Care for Military and Veterans Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016 --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016, --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Department of the Interior, Environment, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016 --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016, --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016 --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016, --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Biosimilar User Fee Act Implementation --Coding --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Reimbursement Policy Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development and Procurement Issues (Non-funding) TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues --Regulatory Harmonization Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 Drug Evaluation and Review --Compassionate Use/Expanded Access --Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Senate Innovation for Healthier Americans Initiative --Biomarkers and Regulatory Science Improvements --Combination Products --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Information Disclosures --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --PATH Act (Senate Discussion Draft) House 21st Century Cures Initiative --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence Vaccines and Infectious Diseases - General Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Government Price Reporting --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Gene Editing Technologies --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -----Report Language on Heritable Genetic Modification Restriction NIH Precision Medicine Initiative Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
NIH Precision Medicine Initiative Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development and Procurement Issues (Non-funding) House 21st Century Cures Initiative --Longitudinal Study of Chronic Diseases Senate Innovation for Healthier Americans Initiative --Longitudinal Study of Chronic Diseases Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Non-funding) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --PATH Act (Senate Discussion Draft/Innovation for Healthier Americans Initiative) --ADAPT Act (House Discussion Draft/21st Century Cures Initiative)
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for the National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014, Section 9003 Funding for Biofuels --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development, and Procurement Issues (Non-funding) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft)
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Naming --Interchangeability and Pharmacy Substitution --Implementation of Affordable Care Act --Patent Certification --Reimbursement Policy Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Funding for FDA --H.R. 3049/S. 1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --HR 1078: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Drug Evaluation and Review --Implementation of the FDA Safety and Innovation Act/Prescription Drug User Fee Act Orphan Drug Act Tax Credit 21st Century Cures Initiative --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals and Payers --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculation --Reimbursement for Infusion Drugs under Medicare Part B Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 21st Century Cures Initiative --Longitudinal Study of Chronic Diseases Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft)
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Biosimilar User Fee Act Implementation --Coding --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Reimbursement Policy Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development and Procurement Issues (Non-funding) TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues --Regulatory Harmonization Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 Drug Evaluation and Review --Compassionate Use/Expanded Access --Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Senate Innovation for Healthier Americans Initiative --Biomarkers and Regulatory Science Improvements --Combination Products --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Information Disclosures --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --PATH Act (Senate Discussion Draft) House 21st Century Cures Initiative --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence Vaccines and Infectious Diseases - General Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Government Price Reporting --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Gene Editing Technologies --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -----Report Language on Heritable Genetic Modification Restriction NIH Precision Medicine Initiative Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016 --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016, --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Naming --Interchangeability and Pharmacy Substitution --Implementation of Affordable Care Act --Patent Certification --Reimbursement Policy Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Funding for FDA --H.R. 3049/S. 1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --HR 1078: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Drug Evaluation and Review --Implementation of the FDA Safety and Innovation Act/Prescription Drug User Fee Act Orphan Drug Act Tax Credit 21st Century Cures Initiative --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals and Payers --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculation --Reimbursement for Infusion Drugs under Medicare Part B Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for the National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014, Section 9003 Funding for Biofuels --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2967: National Biodefense Strategy Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for FY 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Senate Innovation for Healthier Americans ---Longitudinal Study of Chronic Diseases Precision Medicine Initiative
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of Technology Policy (OTP), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Vice President of the U.S.
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2016 · second_quarter · Q2
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act 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 Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, 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 Gene Editing Technologies ---S.3040-H.R.5325: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative Senate Innovation for Healthier Americans ---Longitudinal Study of Chronic Diseases Combating Antibiotic-Resistant Bacteria (CARB) Initiative
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
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 Biofuels ---H.R.5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biomass Crop Assistance Program ---H.R.5054-S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 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 Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054 -S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R.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 Renewable Chemicals/Bio-based Products ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Funding for the USDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Energy Basic Research Funding ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017
Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act 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
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), SENATE, U.S. Trade Representative (USTR), White House Office
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2016 · first_quarter · Q1
Funding for the USDA --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biomass Crop Assistance Program --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for FDA --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for Centers for Disease Control and Prevention Vaccine Programs --Departments of Labor, HHS, Education, and Related Agencies 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 2017 --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for Biofuels --Department of Defense Funding of Advanced Biofuels --Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Funding for Renewable Chemicals/Bio-based Products --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Energy Basic Research Funding --Advanced Research Projects Agency --DOE Office of Science --Energy and Water Development and Related Agencies Appropriations Act for FY 2017
Biosimilars --Coding --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Patent Certification --Brazil Biologics Regulations Funding for National Institutes of Health --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for Centers for Disease Control and Prevention Vaccine Programs --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 340B Drug Pricing Program --Implementation of Affordable Care Act --Program Implementation & Oversight --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Drug Importation --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Biodefense Research, Development and Procurement Issues (Nonfunding) Reimbursement for Innovative Products --Medicare Part B Physician-Administered Products --Medicare Part D Prescription Drug Program: ----CMS Proposed Rule on Protected Classes --Value-based Contracting and Communications Drug Evaluation and Review --Compassionate Use/Expanded Access --FDA Proposed Rule on Changes to Drug Labeling --Implementation of the FDA Safety and Innovation Act --Reauthorization of the Prescription Drug User Fee Act --Special Medical Use/Limited Population Drug ---- ADAPT Act (House Discussion Draft) Senate Innovation for Healthier Americans --Biomarkers and Regulatory Science Improvements --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives ----S. 195: PATH Act --Communication with Healthcare Professionals and Payors --Priority Review Voucher Programs Priority Review of Generic Drugs ----S. 2615: Increasing Competition in Pharmaceuticals Act Vaccines and Infectious Diseases - General Government Price Reporting --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Gene Editing Technologies --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act Drug Manufacturing, Quality & Distribution --Supply Chain Integrity and Traceability Affordable Care Act Implementation --Third Party Support of Patient Premiums and Cost-Sharing Obligations Combating Antibiotic-Resistant Bacteria (CARB) Initiative Vaccine Access/Financing --Adult Immunization (Senate Discussion Draft) --Implementation of Affordable Care Act --Senate Chronic Care Working Group Proposals --Vaccine Injury Compensation Program TransPacific Partnership --Data and Intellectual Property Protection for Pharmaceuticals --Reimbursement Transparency Orphan Drug Act Tax Credit UN Commission on Access to Medicines
Funding for National Institutes of Health --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Biodefense Research, Development and Procurement Issues Senate Innovation for Healthier Americans --Longitudinal Study of Chronic Diseases Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Gene Editing Technologies --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative Combating Antibiotic-Resistant Bacteria (CARB) Initiative
Biodefense Research, Development and Procurement Issues (Nonfunding) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017
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)
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2015 · fourth_quarter · Q4
Funding for National Institutes of Health ---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 (Non-funding) Senate Innovation for Healthier Americans Initiative ---Longitudinal Study of Chronic Diseases Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.2029: Consolidated Appropriations Act for FY 2016 Gene Editing Technologies ---H.R. 2029: Consolidated Appropriations Act for 2016 Precision Medicine Initiative
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
Funding for the USDA ---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 Funding for FDA ---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 Funding for the National Institutes of Health ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Biofuels ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Biorefineries ---H.R.2029: Consolidated Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.2029: Consolidated Appropriations Act for FY 2016
Biodefense Research, Development, and Procurement Issues (Non-funding) Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---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
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)
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2015 · third_quarter · Q3
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for the National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014, Section 9003 Funding for Biofuels --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015
Biosimilars --Biosimilar User Fee Act Implementation --Coding --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Reimbursement Policy Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development and Procurement Issues (Non-funding) TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues --Regulatory Harmonization Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 Drug Evaluation and Review --Compassionate Use/Expanded Access --Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Senate Innovation for Healthier Americans Initiative --Biomarkers and Regulatory Science Improvements --Combination Products --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Information Disclosures --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --PATH Act (Senate Discussion Draft) House 21st Century Cures Initiative --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence Vaccines and Infectious Diseases - General Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Government Price Reporting --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Gene Editing Technologies --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -----Report Language on Heritable Genetic Modification Restriction NIH Precision Medicine Initiative Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act
NIH Precision Medicine Initiative Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development and Procurement Issues (Non-funding) House 21st Century Cures Initiative --Longitudinal Study of Chronic Diseases Senate Innovation for Healthier Americans Initiative --Longitudinal Study of Chronic Diseases Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Biodefense Research, Development and Procurement Issues (Non-funding) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --PATH Act (Senate Discussion Draft/Innovation for Healthier Americans Initiative) --ADAPT Act (House Discussion Draft/21st Century Cures Initiative)
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)
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2015 · second_quarter · Q2
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016 --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016, --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2015 · first_quarter · 1A
Funding for the USDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -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 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 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 Biomass Crop Assistance Program -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees -H.R. 1078: FDA Safety over Sequestration Act Funding for Biofuels -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -Department of Defense Appropriations Act for FY 2016 -Department of Defense Funding of Advanced Biofuels -Energy and Water Development 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 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative - Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
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
Biodefense Research, Development, and Procurement Issues (Non-funding) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft)
Biosimilars --Naming --Interchangeability and Pharmacy Substitution --Implementation of Affordable Care Act --Patent Certification --Reimbursement Policy Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Funding for FDA --H.R. 3049/S. 1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --HR 1078: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Drug Evaluation and Review --Implementation of the FDA Safety and Innovation Act/Prescription Drug User Fee Act Orphan Drug Act Tax Credit 21st Century Cures Initiative --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals and Payers --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculation --Reimbursement for Infusion Drugs under Medicare Part B Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015
Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 21st Century Cures Initiative --Longitudinal Study of Chronic Diseases Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft)
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)
Biodefense Research, Development, and Procurement Issues (Non-funding) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative -ADAPT Act (House Discussion Draft) Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Genetically Engineered (GE) Animals -FDA Approval -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Amendment on GE Salmon Labeling --Amendment to Restrict FDA Approval of GE Salmon Review and Labeling of Food Derived From Biotechnology -H.R. 1599: Safe and Accurate Food Labeling Act of 2015 -U.S. Government Policy Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification USDA/APHIS Agricultural Biotechnology Regulations -Coexistence of Production Systems -Efficient Science-Based Review of Biotech Products
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 Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 21st Century Cures Initiative -Longitudinal Study of Chronic Diseases Combating Antibiotic-Resistant Bacteria (CARB) Initiative -ADAPT Act (House Discussion Draft) Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
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
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
Funding for the USDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -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 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 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 Biomass Crop Assistance Program -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees -H.R. 1078: FDA Safety over Sequestration Act Funding for Biofuels -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -Department of Defense Appropriations Act for FY 2016 -Department of Defense Funding of Advanced Biofuels -Energy and Water Development 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 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative - Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
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 Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 21st Century Cures Initiative -Longitudinal Study of Chronic Diseases Combating Antibiotic-Resistant Bacteria (CARB) Initiative -ADAPT Act (House Discussion Draft) Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Biodefense Research, Development, and Procurement Issues (Non-funding) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative -ADAPT Act (House Discussion Draft) Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Genetically Engineered (GE) Animals -FDA Approval -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Amendment on GE Salmon Labeling --Amendment to Restrict FDA Approval of GE Salmon Review and Labeling of Food Derived From Biotechnology -H.R. 1599: Safe and Accurate Food Labeling Act of 2015 -U.S. Government Policy Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification USDA/APHIS Agricultural Biotechnology Regulations -Coexistence of Production Systems -Efficient Science-Based Review of Biotech Products
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