NICK MAGALLANES

21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases

21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases

21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Biofuels ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Farm Bill Reauthorization Funding for Biomass Crop Assistance Program ---Farm Bill Reauthorization ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Biorefineries ---Farm Bill Reauthorization ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Renewable Chemicals/Bio-based Products ---USDA BioPreferred Program ---EPA Safer Choice Program ---Farm Bill Reauthorization ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for 2017 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the USDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018

21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases

Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act --S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3 Opioid Abuse

21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases

Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Intellectual Property International Enforcement ---India ---Saudi Arabia Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines

21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases

21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases

Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act --S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3 Opioid Abuse

21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases

Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchronous Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Intellectual Property International Enforcement ---India ---Saudi Arabia Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines

21st Century Cures Act Implementation ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Government Hiring Freeze ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence 340B Drug Pricing Program ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Program Implementation & Oversight Affordable Care Act - Repeal and Replace ---H.R. 1628: American Health Care Act ---Vaccine Issues Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Act of 2017 Biodefense Research, Development, and Procurement Issues (Nonfunding) ---Implementation of Medical Countermeasures Innovation Act Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Coding ---Interchangeability and Pharmacy Substitution ---Naming Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Government Hiring Freeze ---Regenerative Medicine ---Implementation of the FDA Safety and Innovation Act ---RACE for Children Act (Discussion Draft) ---Reauthorization of the Prescription Drug User Fee Act ---S.204/H.R.878: Right to Try Act of 2017 Drug Importation ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---S.469: Affordable and Safe Prescription Drug Importation Act ---S.Amdt.174 to S.Con.Res.3 ---S.Amdt.178 to S.Con.Res.3: Drug Manufacturing, Quality & Distribution ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Implementation of H.R. 3204: The Drug Quality and Security Act ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2018 Funding for National Institutes of Health ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Generic Drug Entry ---Access to Samples for Testing ---Incentives for Generic Entry Generic Drug Application Review Reforms ---H.R. 749: Lower Drug Costs Through Competition Act ---S. 297: Increasing Competition in Pharmaceuticals Act Government Price Reporting ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 Independent Payment Advisory Board Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations Orphan Drug Act Tax Credit Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Turkish Requirement for Localized Drug Manufacturing UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---Vaccine Injury Compensation Program ---Vaccine Safety Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2018 ---Continuing Appropriations Act for FY 2017 Drug Pricing ---S.Amdt.188 to S.Con.Res.3 ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act (Senator Wyden Discussion Draft) ---Drug Price Gouging Enforcement (Senator Coons Discussion Draft) ---S. 771: Improving Access to Affordable Prescription Drugs Opioid Abuse Longitudinal Study of Chronic Diseases

Genetically Engineered (GE) Animals --Amendment on GE Salmon Labeling --Amendment to Restrict FDA Approval of GE Salmon --Labeling --One Health Legislation (Senate Discussion Draft) --FDA Approval --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Review and Labeling of Food Derived From Biotechnology --H.R. 1599: Safe and Accurate Food Labeling Act of 2015 --S.2609: The Biotech Labeling Solutions Act --U.S. Government Policy USDA/APHIS Agricultural Biotechnology Regulations --Efficient Science-Based Review of Biotech Products --USDA Decision on GE Crops Environmental Impact Statement --Co-existence of Production Systems --Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Biosimilars --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Brazil Biologics Regulations 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

Biosimilars ---Implementation of Affordable Care Act ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Biosimilar User Fee Act Reauthorization and Implementation ---Colombia Biologics Regulations ---Access to Samples for Testing ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 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 Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Amendment to Restrict FDA Approval of GE Salmon ---Labeling ---S. 2634: The One Health Act ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Review and Labeling of Food Derived from Biotechnology ---H.R. 1599: Safe and Accurate Food Labeling Act of 2015 ---S. 764: Senate biotech labeling compromise bill ---S.2609: The Biotech Labeling Solutions Act USDA/APHIS Agricultural Biotechnology Regulations ---Co-existence of Production Systems ---Efficient Science-Based Review of Biotech Products ---Potential Revisions to Part 340 Regulations

Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---PCAOB Audit Cost Increases Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1965: Small Company Disclosure Simplification Act

21st Century Cures/ Senate Innovation for Healthier Americans ---H.R.34: 21st Century Cures Act ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---S. 524: Comprehensive Addiction and Recovery Act of 2016 ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---S. 3239/H.R. 5858: RACE for Children Act 340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 ---CREATES Act (House Energy & Commerce Committee Discussion Draft) Drug Evaluation and Review ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---CREATES Act (House Energy & Commerce Committee Discussion Draft) ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Independent Payment Advisory Board Orphan Drug Act Tax Credit Precision Medicine Initiative Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part B Physician-Administered Products ---Value-based Contracting and Communications TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---H.R. 3299: Strengthening Public Health Emergency Response Act ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---Supplemental Funding for Combating Zika ---Vaccine Injury Compensation Program ---Vaccine Safety

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

Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---PCAOB Audit Cost Increases Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1965: Small Company Disclosure Simplification Act

Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biofuels (Non-Funding) ---Production Tax Credit Extension Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Inversions ---Treatment of Financial Interests as Stock or Indebtedness: Section 385 Proposed Regulations Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---S. 2271: The Renewable Chemical Production Tax Credit Act ---S. 1656/H.R. 2883: Master Limited Partnership Parity Act ---Expansion of Master Limited Partnerships to Renewable Chemicals Research & Development Tax Credit Reforms ---Extension ---H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities ---Permanency ---Refundable R&D Credit ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Orphan Drug Tax Credit

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

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

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

Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biofuels (Non-Funding) ---Production Tax Credit Extension Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Inversions ---Treatment of Financial Interests as Stock or Indebtedness: Section 385 Proposed Regulations Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---S. 2271: The Renewable Chemical Production Tax Credit Act ---S. 1656/H.R. 2883: Master Limited Partnership Parity Act ---Expansion of Master Limited Partnerships to Renewable Chemicals Research & Development Tax Credit Reforms ---Extension ---H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities ---Permanency ---Refundable R&D Credit ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Orphan Drug Tax Credit

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

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

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

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

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

21st Century Cures/ Senate Innovation for Healthier Americans ---H.R. 34: The 21st Century Cures Act ---Longitudinal Study of Chronic Diseases Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative

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

21st Century Cures/ Senate Innovation for Healthier Americans ---H.R.34: 21st Century Cures Act ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---S. 524: Comprehensive Addiction and Recovery Act of 2016 ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---S. 3239/H.R. 5858: RACE for Children Act 340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 ---CREATES Act (House Energy & Commerce Committee Discussion Draft) Drug Evaluation and Review ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---CREATES Act (House Energy & Commerce Committee Discussion Draft) ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Independent Payment Advisory Board Orphan Drug Act Tax Credit Precision Medicine Initiative Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part B Physician-Administered Products ---Value-based Contracting and Communications TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---H.R. 3299: Strengthening Public Health Emergency Response Act ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---Supplemental Funding for Combating Zika ---Vaccine Injury Compensation Program ---Vaccine Safety

Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biofuels (Non-Funding) ---Production Tax Credit Extension Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Inversions ---Treatment of Financial Interests as Stock or Indebtedness: Section 385 Proposed Regulations Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---S. 2271: The Renewable Chemical Production Tax Credit Act ---S. 1656/H.R. 2883: Master Limited Partnership Parity Act ---Expansion of Master Limited Partnerships to Renewable Chemicals Research & Development Tax Credit Reforms ---Extension ---H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities ---Permanency ---Refundable R&D Credit ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Orphan Drug Tax Credit

21st Century Cures/ Senate Innovation for Healthier Americans ---H.R.34: 21st Century Cures Act ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---S. 524: Comprehensive Addiction and Recovery Act of 2016 ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---S. 3239/H.R. 5858: RACE for Children Act 340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 ---CREATES Act (House Energy & Commerce Committee Discussion Draft) Drug Evaluation and Review ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---CREATES Act (House Energy & Commerce Committee Discussion Draft) ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Independent Payment Advisory Board Orphan Drug Act Tax Credit Precision Medicine Initiative Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part B Physician-Administered Products ---Value-based Contracting and Communications TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---H.R. 3299: Strengthening Public Health Emergency Response Act ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---Supplemental Funding for Combating Zika ---Vaccine Injury Compensation Program ---Vaccine Safety

21st Century Cures/ Senate Innovation for Healthier Americans ---H.R. 34: The 21st Century Cures Act ---Patient Access to Approved Drugs Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part B Physician-Administered Products ---Value-based Contracting and Communications

21st Century Cures/ Senate Innovation for Healthier Americans ---H.R. 34: The 21st Century Cures Act ---Longitudinal Study of Chronic Diseases Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative

Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biofuels (Non-Funding) ---Production Tax Credit Extension Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Inversions ---Treatment of Financial Interests as Stock or Indebtedness: Section 385 Proposed Regulations Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---S. 2271: The Renewable Chemical Production Tax Credit Act ---S. 1656/H.R. 2883: Master Limited Partnership Parity Act ---Expansion of Master Limited Partnerships to Renewable Chemicals Research & Development Tax Credit Reforms ---Extension ---H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities ---Permanency ---Refundable R&D Credit ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Orphan Drug Tax Credit

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

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

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

Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---PCAOB Audit Cost Increases Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1965: Small Company Disclosure Simplification Act

Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---PCAOB Audit Cost Increases Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1965: Small Company Disclosure Simplification Act

Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---PCAOB Audit Cost Increases Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1965: Small Company Disclosure Simplification Act

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

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

21st Century Cures/ Senate Innovation for Healthier Americans ---H.R.34: 21st Century Cures Act ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---S. 524: Comprehensive Addiction and Recovery Act of 2016 ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---S. 3239/H.R. 5858: RACE for Children Act 340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 ---CREATES Act (House Energy & Commerce Committee Discussion Draft) Drug Evaluation and Review ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---CREATES Act (House Energy & Commerce Committee Discussion Draft) ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Independent Payment Advisory Board Orphan Drug Act Tax Credit Precision Medicine Initiative Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part B Physician-Administered Products ---Value-based Contracting and Communications TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---H.R. 3299: Strengthening Public Health Emergency Response Act ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---Supplemental Funding for Combating Zika ---Vaccine Injury Compensation Program ---Vaccine Safety

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 Biofuels ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 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 Funding for Renewable Chemicals/Bio-based Products ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for 2017 ---H.R. 5293/S.3000: Department of Defense 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

Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Labeling ---S. 2634: The One Health Act Review and Labeling of Food Derived From Biotechnology ---S. 764: Senate Biotech Labeling Compromise Bill USDA/APHIS Agricultural Biotechnology Regulations ---Co-existence of Production Systems ---Potential Revisions to Part 340 Regulations

TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization ---Ag-Biotech Issues Biosimilars ---Colombia Biologics Regulations ---Mexico Biologics Regulations 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 Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Like-minded Countries Initiatives ---Asynchronous Approvals Intellectual Property International Enforcement ---Compulsory Licensing ---Colombia ---India UN High Level Commission on Access to Medicines

Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 ---CREATES Act (House Energy & Commerce Committee Discussion Draft) Drug 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 Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Efficient Science-Based Review of Biotech Products ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Labeling ---S. 2634: The One Health Act Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Potential Revisions to Part 340 Regulations

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 Biofuels ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 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 Funding for Renewable Chemicals/Bio-based Products ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for 2017 ---H.R. 5293/S.3000: Department of Defense 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

Biosimilars ---Brazil Biologics Regulations ---Colombia Biologics Regulations ---India Biologics Regulations ---Mexico Biologics Regulations 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 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchrony Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines

21st Century Cures/ Senate Innovation for Healthier Americans ---H.R.34: 21st Century Cures Act ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---S. 524: Comprehensive Addiction and Recovery Act of 2016 ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---S. 3239/H.R. 5858: RACE for Children Act 340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 ---CREATES Act (House Energy & Commerce Committee Discussion Draft) Drug Evaluation and Review ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---CREATES Act (House Energy & Commerce Committee Discussion Draft) ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Independent Payment Advisory Board Orphan Drug Act Tax Credit Precision Medicine Initiative Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part B Physician-Administered Products ---Value-based Contracting and Communications TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---H.R. 3299: Strengthening Public Health Emergency Response Act ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---Supplemental Funding for Combating Zika ---Vaccine Injury Compensation Program ---Vaccine Safety

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 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

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

Biosimilars ---Implementation of Affordable Care Act ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Biosimilar User Fee Act Reauthorization and Implementation ---Colombia Biologics Regulations ---Access to Samples for Testing ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 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 Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Amendment to Restrict FDA Approval of GE Salmon ---Labeling ---S. 2634: The One Health Act ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Review and Labeling of Food Derived from Biotechnology ---H.R. 1599: Safe and Accurate Food Labeling Act of 2015 ---S. 764: Senate biotech labeling compromise bill ---S.2609: The Biotech Labeling Solutions Act USDA/APHIS Agricultural Biotechnology Regulations ---Co-existence of Production Systems ---Efficient Science-Based Review of Biotech Products ---Potential Revisions to Part 340 Regulations

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 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 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchrony Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Intellectual Property International Enforcement ---Colombia ---Compulsory Licensing Transatlantic Trade and Investment Partnership ---Ag-Biotech Issues ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines ---Intellectual Property Provisions

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

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 ---Patient Access to Approved Drugs

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

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 Biofuels ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 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 Funding for Renewable Chemicals/Bio-based Products ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for 2017 ---H.R. 5293/S.3000: Department of Defense 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

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

Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---PCAOB Audit Cost Increases Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1965: Small Company Disclosure Simplification Act

Biosimilars ---Implementation of Affordable Care Act ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Biosimilar User Fee Act Reauthorization and Implementation ---Colombia Biologics Regulations ---Access to Samples for Testing ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 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 Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Amendment to Restrict FDA Approval of GE Salmon ---Labeling ---S. 2634: The One Health Act ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Review and Labeling of Food Derived from Biotechnology ---H.R. 1599: Safe and Accurate Food Labeling Act of 2015 ---S. 764: Senate biotech labeling compromise bill ---S.2609: The Biotech Labeling Solutions Act USDA/APHIS Agricultural Biotechnology Regulations ---Co-existence of Production Systems ---Efficient Science-Based Review of Biotech Products ---Potential Revisions to Part 340 Regulations

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

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

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

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

TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization ---Ag-Biotech Issues Biosimilars ---Colombia Biologics Regulations ---Mexico Biologics Regulations 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 Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Like-minded Countries Initiatives ---Asynchronous Approvals Intellectual Property International Enforcement ---Compulsory Licensing ---Colombia ---India UN High Level Commission on Access to Medicines

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

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 Biofuels ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 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 Funding for Renewable Chemicals/Bio-based Products ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for 2017 ---H.R. 5293/S.3000: Department of Defense 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

Government Price Reporting ---H.R.5325/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 ---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 ---Patient Access to Approved Drugs

21st Century Cures/ Senate Innovation for Healthier Americans ---H.R. 34: The 21st Century Cures Act ---Longitudinal Study of Chronic Diseases Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative

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 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

21st Century Cures/ Senate Innovation for Healthier Americans ---H.R.34: 21st Century Cures Act ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---S. 524: Comprehensive Addiction and Recovery Act of 2016 ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---S. 3239/H.R. 5858: RACE for Children Act 340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 ---CREATES Act (House Energy & Commerce Committee Discussion Draft) Drug Evaluation and Review ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---CREATES Act (House Energy & Commerce Committee Discussion Draft) ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Independent Payment Advisory Board Orphan Drug Act Tax Credit Precision Medicine Initiative Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part B Physician-Administered Products ---Value-based Contracting and Communications TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---H.R. 3299: Strengthening Public Health Emergency Response Act ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---Supplemental Funding for Combating Zika ---Vaccine Injury Compensation Program ---Vaccine Safety

Drug Patent Settlements ---S. 2019: Preserve Access to Affordable Generics Act of 2015 ---S.1137: The PATENTS Act of 2015 Intellectual Property International Enforcement ---Colombia ---Compulsory Licensing Inter Partes Review ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 ---Implementation of the America Invents Act of 2011 ---S.1137: The PATENTS Act of 2015 Patent Reform ---H.R. 9: Innovation Act ---Implementation of the America Invents Act of 2011 ---S.1137: The PATENTS Act of 2015 Transatlantic Trade and Investment Partnership ---Intellectual Property Issues TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals World Trade Organization - Special 301 Submissions ---Latin American Issues UN High Level Commission on Access to Medicines ---Intellectual Property Provisions

Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---Financial CHOICE Act (House Discussion Draft) ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---PCAOB Audit Cost Increases Proxy Advisory Services ---Financial CHOICE Act (House Discussion Draft) ---H.R. 5311: Corporate Governance Reform and Transparency Act ---Impact of Policies on Small Public Companies Reform of SEC Regulation D ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---Financial CHOICE Act (House Discussion Draft) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption Short Selling Transparency ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 XBRL Exemption for Small Public Companies ---Financial CHOICE Act (House Discussion Draft) ---H.R. 1965: Small Company Disclosure Simplification Act

21st Century Cures/ Senate Innovation for Healthier Americans ---H.R.34: 21st Century Cures Act ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---S. 524: Comprehensive Addiction and Recovery Act of 2016 ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---S. 3239/H.R. 5858: RACE for Children Act 340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 ---CREATES Act (House Energy & Commerce Committee Discussion Draft) Drug Evaluation and Review ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---CREATES Act (House Energy & Commerce Committee Discussion Draft) ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Independent Payment Advisory Board Orphan Drug Act Tax Credit Precision Medicine Initiative Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part B Physician-Administered Products ---Value-based Contracting and Communications TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---H.R. 3299: Strengthening Public Health Emergency Response Act ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---Supplemental Funding for Combating Zika ---Vaccine Injury Compensation Program ---Vaccine Safety

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

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 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 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchrony Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations Intellectual Property International Enforcement ---Colombia ---Compulsory Licensing Transatlantic Trade and Investment Partnership ---Ag-Biotech Issues ---Intellectual Property Issues ---Regulatory Harmonization TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines ---Intellectual Property Provisions

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

Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Interchangeability and Pharmacy Substitution ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Labeling ---S. 2634: The One Health Act Review and Labeling of Food Derived From Biotechnology ---S. 764: Senate Biotech Labeling Compromise Bill USDA/APHIS Agricultural Biotechnology Regulations ---Co-existence of Production Systems ---Potential Revisions to Part 340 Regulations

Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 ---CREATES Act (House Energy & Commerce Committee Discussion Draft) Drug 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 Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Efficient Science-Based Review of Biotech Products ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Labeling ---S. 2634: The One Health Act Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law USDA/APHIS Agricultural Biotechnology Regulations ---Efficient Science-Based Review of Biotech Products ---Potential Revisions to Part 340 Regulations

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 Biofuels ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for 2017 ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 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 Funding for Renewable Chemicals/Bio-based Products ---H.R. 4909/S.2943: National Defense Authorization Act (NDAA) for 2017 ---H.R. 5293/S.3000: Department of Defense 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

Biosimilars ---Brazil Biologics Regulations ---Colombia Biologics Regulations ---India Biologics Regulations ---Mexico Biologics Regulations 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 Foreign Agricultural Biotechnology Laws and Regulations ---Asynchrony Approvals ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines

21st Century Cures/ Senate Innovation for Healthier Americans ---H.R. 34: The 21st Century Cures Act ---Longitudinal Study of Chronic Diseases Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative

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 ---Patient Access to Approved Drugs

21st Century Cures/ Senate Innovation for Healthier Americans ---H.R.34: 21st Century Cures Act ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Use of Real-World Evidence ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---S. 1878: Advancing Hope Act of 2015 ---S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---S. 524: Comprehensive Addiction and Recovery Act of 2016 ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---S. 3239/H.R. 5858: RACE for Children Act 340B Drug Pricing Program ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Implementation of Affordable Care Act ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act of 2015 Biosimilars ---Access to Samples for Testing ---Biosimilar User Fee Act Reauthorization and Implementation ---Brazil Biologics Regulations ---Coding ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 ---CREATES Act (House Energy & Commerce Committee Discussion Draft) Drug Evaluation and Review ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---H.R. 2029: The Patient Choice Act ---H.R. 4475: Compassionate Freedom of Choice Act ---S. 2912: Trickett Wendler Right to Try Act of 2016 Drug Importation ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Drug Manufacturing, Quality & Distribution ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Vial and Dose Size Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---Supplemental Funding for Combating Zika Gene Editing Technologies ---H.R. 5926/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---CREATES Act (House Energy & Commerce Committee Discussion Draft) ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Independent Payment Advisory Board Orphan Drug Act Tax Credit Precision Medicine Initiative Reimbursement for Innovative Products ---CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part B Physician-Administered Products ---Value-based Contracting and Communications TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals UN High Level Commission on Access to Medicines Vaccines and Infectious Diseases ---H.R. 3299: Strengthening Public Health Emergency Response Act ---H.R.5325: Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriation Act for 2017, and Zika Response and Preparedness Act ---S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---Supplemental Funding for Combating Zika ---Vaccine Injury Compensation Program ---Vaccine Safety

Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biofuels (Non-Funding) ---Production Tax Credit Extension Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Inversions ---Treatment of Financial Interests as Stock or Indebtedness: Section 385 Proposed Regulations Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---S. 2271: The Renewable Chemical Production Tax Credit Act ---S. 1656/H.R. 2883: Master Limited Partnership Parity Act ---Expansion of Master Limited Partnerships to Renewable Chemicals Research & Development Tax Credit Reforms ---Extension ---H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities ---Permanency ---Refundable R&D Credit ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Orphan Drug Tax Credit

Bayh-Dole Act/Tech Transfer ---March-In Rights Drug Patent Settlements ---S. 2019: Preserve Access to Affordable Generics Act of 2015 Intellectual Property International Enforcement ---Compulsory Licensing ---Colombia ---India Inter Partes Review ---Implementation of the American Invents Act of 2011 ---S.1137: The PATENTS Act of 2015 Patent Reform ---H.R. 9: Innovation Act ---S.1137: The PATENTS Act of 2015 TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Transatlantic Trade and Investment Partnership ---Intellectual Property Issues UN High-Level Commission on Access to Medicines