KRISTIN MURPHY

Prescription Drug Costs. Drug Pricing. Pharmaceutical Exclusivity. H.R.2831: The Prompt Approval of Safe Generic Drugs Act. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. 12-Year Exclusivity. Contract Genericization. 30-Month Stays. Labeling of Generic Drugs and Biosimilars. Modern Labeling. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Orange Book. Drug Shortages. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Expediting Review of Facility Changes. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Naming. Biosimilars Insulin. Pass-through Payments for Biosimilars. Cost Sharing for Biosimilars. FDA Inspections. FDA and Future Public Health Emergencies. Buy American Proposals. Issues Related to COVID-19. Citizens Petitions. H.R.2843: STOP GAMES Act of 2021.

Medicare Part D Reform. Medicare Part D Program and Generic Drugs. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. Medicare Part D Tiering. H.R.2846:Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. Medicare Shared Savings Program. H.R.2869/S.1427 - Increasing Access to Biosimilars Act of 2021. ASP+8%. H.R.2815:BIOSIM Act.

Prescription Drug Costs. Drug Pricing. Pharmaceutical Exclusivity. H.R.2831: The Prompt Approval of Safe Generic Drugs Act. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. 12-Year Exclusivity. Contract Genericization. 30-Month Stays. Labeling of Generic Drugs and Biosimilars. Modern Labeling. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Orange Book. Drug Shortages. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Expediting Review of Facility Changes. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Naming. Biosimilars Insulin. Pass-through Payments for Biosimilars. Cost Sharing for Biosimilars. FDA Inspections. FDA and Future Public Health Emergencies. Buy American Proposals. Issues Related to COVID-19. Citizens Petitions. H.R.2843: STOP GAMES Act of 2021.

Medicare Part D Reform. Medicare Part D Program and Generic Drugs. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. Medicare Part D Tiering. H.R.2846:Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. Medicare Shared Savings Program. H.R.2869/S.1427 - Increasing Access to Biosimilars Act of 2021. ASP+8%. H.R.2815:BIOSIM Act.

Medicare Part D Reform. Medicare Part D Program and Generic Drugs. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. Medicare Part D Tiering. H.R.2846:Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. Medicare Shared Savings Program. H.R.2869/S.1427 - Increasing Access to Biosimilars Act of 2021. ASP+8%. H.R.2815:BIOSIM Act.

Prescription Drug Costs. Drug Pricing. Pharmaceutical Exclusivity. H.R.2831: The Prompt Approval of Safe Generic Drugs Act. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. 12-Year Exclusivity. Contract Genericization. 30-Month Stays. Labeling of Generic Drugs and Biosimilars. Modern Labeling. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Orange Book. Drug Shortages. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Expediting Review of Facility Changes. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Naming. Biosimilars Insulin. Pass-through Payments for Biosimilars. Cost Sharing for Biosimilars. FDA Inspections. FDA and Future Public Health Emergencies. Buy American Proposals. Issues Related to COVID-19. Citizens Petitions. H.R.2843: STOP GAMES Act of 2021.

General Trade Issues. Drug Supply Chain. S.1176: Onshoring Essential Antibiotics Act. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. H.R.2653/S.1203: Medical Manufacturing, Economic Development, and Sustainability (MMEDS) Act of 2021. S.1366: Pharmaceutical Supply Chain Defense and Enhancement Act. S.1367: United States Pharmaceutical Supply Chain Review Act. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. United States-Mexico-Canada (USMCA) Implementation. US-India Trade Discussions. TRIPS Waivers.

Patent Settlements. H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act. H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021. Patent Abuse. H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act. REMEDY Act. BPCIA Patent Dance. Inter Partes Review. Section 101 of the Patent Act. Product Hopping. H.R.2873/S.1435: Affordable Prescriptions for Patients Act of 2021. TAB Appointments Clause (Arthrex Case). Enhancing Quality of Patents through the PTAB.

Patent Settlements. H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act. H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021. Patent Abuse. H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act. REMEDY Act. BPCIA Patent Dance. Inter Partes Review. Section 101 of the Patent Act. Product Hopping. H.R.2873/S.1435: Affordable Prescriptions for Patients Act of 2021. TAB Appointments Clause (Arthrex Case). Enhancing Quality of Patents through the PTAB.

Patent Settlements. H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act. H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021. Patent Abuse. H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act. REMEDY Act. BPCIA Patent Dance. Inter Partes Review. Section 101 of the Patent Act. Product Hopping. H.R.2873/S.1435: Affordable Prescriptions for Patients Act of 2021. TAB Appointments Clause (Arthrex Case). Enhancing Quality of Patents through the PTAB.

General Trade Issues. Drug Supply Chain. S.1176: Onshoring Essential Antibiotics Act. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. H.R.2653/S.1203: Medical Manufacturing, Economic Development, and Sustainability (MMEDS) Act of 2021. S.1366: Pharmaceutical Supply Chain Defense and Enhancement Act. S.1367: United States Pharmaceutical Supply Chain Review Act. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. United States-Mexico-Canada (USMCA) Implementation. US-India Trade Discussions. TRIPS Waivers.

General Trade Issues. Drug Supply Chain. S.1176: Onshoring Essential Antibiotics Act. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. H.R.2653/S.1203: Medical Manufacturing, Economic Development, and Sustainability (MMEDS) Act of 2021. S.1366: Pharmaceutical Supply Chain Defense and Enhancement Act. S.1367: United States Pharmaceutical Supply Chain Review Act. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. United States-Mexico-Canada (USMCA) Implementation. US-India Trade Discussions. TRIPS Waivers.

General Trade Issues. Drug Supply Chain. S.1176: Onshoring Essential Antibiotics Act. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. H.R.2653/S.1203: Medical Manufacturing, Economic Development, and Sustainability (MMEDS) Act of 2021. S.1366: Pharmaceutical Supply Chain Defense and Enhancement Act. S.1367: United States Pharmaceutical Supply Chain Review Act. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. United States-Mexico-Canada (USMCA) Implementation. US-India Trade Discussions. TRIPS Waivers.

General Trade Issues. Drug Supply Chain. S.1176: Onshoring Essential Antibiotics Act. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. H.R.2653/S.1203: Medical Manufacturing, Economic Development, and Sustainability (MMEDS) Act of 2021. S.1366: Pharmaceutical Supply Chain Defense and Enhancement Act. S.1367: United States Pharmaceutical Supply Chain Review Act. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. United States-Mexico-Canada (USMCA) Implementation. US-India Trade Discussions. TRIPS Waivers.

Medicare Part D Reform. Medicare Part D Program and Generic Drugs. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. Medicare Part D Tiering. H.R.2846:Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. Medicare Shared Savings Program. H.R.2869/S.1427 - Increasing Access to Biosimilars Act of 2021. ASP+8%. H.R.2815:BIOSIM Act.

Patent Settlements. H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act. H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021. Patent Abuse. H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act. REMEDY Act. BPCIA Patent Dance. Inter Partes Review. Section 101 of the Patent Act. Product Hopping. H.R.2873/S.1435: Affordable Prescriptions for Patients Act of 2021. TAB Appointments Clause (Arthrex Case). Enhancing Quality of Patents through the PTAB.

Patent Settlements. H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act. H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021. Patent Abuse. H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act. REMEDY Act. BPCIA Patent Dance. Inter Partes Review. Section 101 of the Patent Act. Product Hopping. H.R.2873/S.1435: Affordable Prescriptions for Patients Act of 2021. TAB Appointments Clause (Arthrex Case). Enhancing Quality of Patents through the PTAB.

Prescription Drug Costs. Drug Pricing. Pharmaceutical Exclusivity. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. Contract Genericization. 30-Month Stays. Labeling of Generic Drugs and Biosimilars. Modern Labeling. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Orange Book. Drug Shortages. S.917: Short on Competition Act. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Naming. Biosimilars Insulin. Pass-through Payments for Biosimilars. Cost Sharing for Biosimilars. Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Buy American Proposals. Issues Related to COVID-19. Secretary Azar Importation Plan.

FDA Funding. H.R.133: Consolidated Appropriations Act, 2021.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.

FDA Funding. H.R.1865: Further Consolidated Appropriations Act, 2020. Section 605 of H.R.1865: Further Consolidated Appropriations Act, 2020. Public Law 115-123: Bipartisan Budget Act of 2018. Public Law 115-141: Consolidated Appropriations Act of 2018.

FDA Funding. H.R.1865: Further Consolidated Appropriations Act, 2020. S.4049: National Defense Authorization Act for Fiscal Year 2021. Public Law 115-141: Consolidated Appropriations Act of 2018.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Legislation to Grant Food and Drug Administration Needed Authority to Recall Unsafe Drug Products, Protect Consumers. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. S.4492: Safe Drugs Act. Country of Manufacture Labeling. Modern Labeling. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. Stockpile of Generic Drugs. H.R.6516: Stockpiling for America's Future Endeavors Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Orange Book. Issues Related to COVID-19. Implementation of Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Rubio Coronavirus Plan. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. FDA Enforcement Discretion. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Purple Book Modernization. Orange Book. Issues Related to COVID-19. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Implementation of H.R.6201: Families First Coronavirus Response Act. Implementation of S.3630: Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.

Patent Settlements. Patent Abuse. Accelerating the Patent Dance. BPCIA Patent Dance. H.R.3666: STRONGER Patents Act of 2019. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019. H.R.3812/S.1209: Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act.

Patent Settlements. Patent Abuse. Accelerating the Patent Dance. BPCIA Patent Dance. H.R.3666: STRONGER Patents Act of 2019. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019. H.R.3812/S.1209: Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act.

Patent Settlements. Patent Abuse. Accelerating the Patent Dance. BPCIA Patent Dance. Inter Partes Review. Section 1498. H.R.3666: STRONGER Patents Act of 2019.

Patent Settlements. Patent Abuse. Accelerating the Patent Dance. BPCIA Patent Dance. H.R.3666: STRONGER Patents Act of 2019. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019. H.R.3812/S.1209: Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. FDA Enforcement Discretion. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Purple Book Modernization. Orange Book. Issues Related to COVID-19. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Implementation of H.R.6201: Families First Coronavirus Response Act. Implementation of S.3630: Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Legislation to Grant Food and Drug Administration Needed Authority to Recall Unsafe Drug Products, Protect Consumers. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. S.4492: Safe Drugs Act. Country of Manufacture Labeling. Modern Labeling. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. Stockpile of Generic Drugs. H.R.6516: Stockpiling for America's Future Endeavors Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Orange Book. Issues Related to COVID-19. Implementation of Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Rubio Coronavirus Plan. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. FDA Enforcement Discretion. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Purple Book Modernization. Orange Book. Issues Related to COVID-19. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Implementation of H.R.6201: Families First Coronavirus Response Act. Implementation of S.3630: Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Legislation to Grant Food and Drug Administration Needed Authority to Recall Unsafe Drug Products, Protect Consumers. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. S.4492: Safe Drugs Act. Country of Manufacture Labeling. Modern Labeling. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. Stockpile of Generic Drugs. H.R.6516: Stockpiling for America's Future Endeavors Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Orange Book. Issues Related to COVID-19. Implementation of Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Rubio Coronavirus Plan. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. FDA Enforcement Discretion. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Purple Book Modernization. Orange Book. Issues Related to COVID-19. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Implementation of H.R.6201: Families First Coronavirus Response Act. Implementation of S.3630: Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. FDA Enforcement Discretion. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Purple Book Modernization. Orange Book. Issues Related to COVID-19. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Implementation of H.R.6201: Families First Coronavirus Response Act. Implementation of S.3630: Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Legislation to Grant Food and Drug Administration Needed Authority to Recall Unsafe Drug Products, Protect Consumers. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. S.4492: Safe Drugs Act. Country of Manufacture Labeling. Modern Labeling. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. Stockpile of Generic Drugs. H.R.6516: Stockpiling for America's Future Endeavors Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Orange Book. Issues Related to COVID-19. Implementation of Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Rubio Coronavirus Plan. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Legislation to Grant Food and Drug Administration Needed Authority to Recall Unsafe Drug Products, Protect Consumers. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. S.4492: Safe Drugs Act. Country of Manufacture Labeling. Modern Labeling. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. Stockpile of Generic Drugs. H.R.6516: Stockpiling for America's Future Endeavors Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Orange Book. Issues Related to COVID-19. Implementation of Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Rubio Coronavirus Plan. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. FDA Enforcement Discretion. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Purple Book Modernization. Orange Book. Issues Related to COVID-19. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Implementation of H.R.6201: Families First Coronavirus Response Act. Implementation of S.3630: Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Patent Settlements. Patent Abuse. BPCIA Patent Dance. Inter Partes Review. H.R.4850/S.659: Biologic Patent Transparency Act. Section 101 of the Patent Act.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. FDA Enforcement Discretion. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Purple Book Modernization. Orange Book. Issues Related to COVID-19. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Implementation of H.R.6201: Families First Coronavirus Response Act. Implementation of S.3630: Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Legislation to Grant Food and Drug Administration Needed Authority to Recall Unsafe Drug Products, Protect Consumers. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. S.4492: Safe Drugs Act. Country of Manufacture Labeling. Modern Labeling. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. Stockpile of Generic Drugs. H.R.6516: Stockpiling for America's Future Endeavors Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Orange Book. Issues Related to COVID-19. Implementation of Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Rubio Coronavirus Plan. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. Medicare Shared Savings Program. H.R.6179: Increasing Access to Biosimilars Act of 2020. S.1895: Lower Health Care Costs Act.

Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. Medicare Shared Savings Program. H.R.6179: Increasing Access to Biosimilars Act of 2020. S.1895: Lower Health Care Costs Act.

Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. Medicare Shared Savings Program. H.R.6179: Increasing Access to Biosimilars Act of 2020. S.1895: Lower Health Care Costs Act.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

General Trade Issues. Pharmaceutical Exclusivity. Quality Supply Chain. Drug Supply Chain. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. H.R.6049/S.3343: Medical Supply Chain Security Act. H.R.6393/S.3538: Strengthening Americas Supply Chain and National Security Act. S. ___More Accurate Supply Chain Information. Air Transport of Pharmaceuticals. United States-Mexico-Canada Agreement (USMCA). U.S.-UK Trade Agreement. U.S.-Kenya Trade Discussions. U.S.-India Trade Discussions. U.S.-European Trade Discussions. U.S.-China Trade Discussions. Secretary Azar Importation Plan.

General Trade Issues. Biologic Exclusivity. Pharmaceutical Exclusivity. Quality Supply Chain. Drug Supply Chain. H.R.6049/S.3343: Medical Supply Chain Security Act. S. ___Strengthening Americas Supply Chain and National Security Act. S. ___More Accurate Supply Chain Information. H.R.___LOSS Act. Air Transport of Pharmaceuticals. United States-Mexico-Canada Agreement (USMCA). U.S.-UK Trade Agreement. U.S.-Kenya Trade Discussions. U.S.-India Trade Discussions. U.S.-European Trade Discussions. U.S.-China Trade Discussions. U.S.-China Phase 1 Trade Deal. Secretary Azar Importation Plan.

Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. Medicare Shared Savings Program. H.R.6179: Increasing Access to Biosimilars Act of 2020. S.1895: Lower Health Care Costs Act.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.

Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. Medicare Shared Savings Program. H.R.6179: Increasing Access to Biosimilars Act of 2020. S.1895: Lower Health Care Costs Act.

Medicare Part D Program and Generic Drugs. Medicare Reimbursement for Biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Medicare Part D Coverage Gap Discount Program. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. Medicare Shared Savings Program. H.R.6179: Increasing Access to Biosimilars Act of 2020. S.1895: Lower Health Care Costs Act.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Legislation to Grant Food and Drug Administration Needed Authority to Recall Unsafe Drug Products, Protect Consumers. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. S.4492: Safe Drugs Act. Country of Manufacture Labeling. Modern Labeling. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. Stockpile of Generic Drugs. H.R.6516: Stockpiling for America's Future Endeavors Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Orange Book. Issues Related to COVID-19. Implementation of Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Rubio Coronavirus Plan. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. FDA Enforcement Discretion. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Purple Book Modernization. Orange Book. Issues Related to COVID-19. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Implementation of H.R.6201: Families First Coronavirus Response Act. Implementation of S.3630: Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

General Trade Issues. Pharmaceutical Exclusivity. Quality Supply Chain. Drug Supply Chain. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. H.R.6049/S.3343: Medical Supply Chain Security Act. H.R.6393/S.3538: Strengthening Americas Supply Chain and National Security Act. S. ___More Accurate Supply Chain Information. Air Transport of Pharmaceuticals. United States-Mexico-Canada Agreement (USMCA). U.S.-UK Trade Agreement. U.S.-Kenya Trade Discussions. U.S.-India Trade Discussions. U.S.-European Trade Discussions. U.S.-China Trade Discussions. Secretary Azar Importation Plan.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Legislation to Grant Food and Drug Administration Needed Authority to Recall Unsafe Drug Products, Protect Consumers. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. S.4492: Safe Drugs Act. Country of Manufacture Labeling. Modern Labeling. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. Stockpile of Generic Drugs. H.R.6516: Stockpiling for America's Future Endeavors Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Orange Book. Issues Related to COVID-19. Implementation of Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Rubio Coronavirus Plan. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. FDA Enforcement Discretion. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Purple Book Modernization. Orange Book. Issues Related to COVID-19. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Implementation of H.R.6201: Families First Coronavirus Response Act. Implementation of S.3630: Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Legislation to Grant Food and Drug Administration Needed Authority to Recall Unsafe Drug Products, Protect Consumers. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. S.4492: Safe Drugs Act. Country of Manufacture Labeling. Modern Labeling. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. Stockpile of Generic Drugs. H.R.6516: Stockpiling for America's Future Endeavors Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Orange Book. Issues Related to COVID-19. Implementation of Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Rubio Coronavirus Plan. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. FDA Enforcement Discretion. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Purple Book Modernization. Orange Book. Issues Related to COVID-19. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Implementation of H.R.6201: Families First Coronavirus Response Act. Implementation of S.3630: Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Legislation to Grant Food and Drug Administration Needed Authority to Recall Unsafe Drug Products, Protect Consumers. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. S.4492: Safe Drugs Act. Country of Manufacture Labeling. Modern Labeling. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. Stockpile of Generic Drugs. H.R.6516: Stockpiling for America's Future Endeavors Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Orange Book. Issues Related to COVID-19. Implementation of Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Rubio Coronavirus Plan. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. FDA Enforcement Discretion. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Purple Book Modernization. Orange Book. Issues Related to COVID-19. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Implementation of H.R.6201: Families First Coronavirus Response Act. Implementation of S.3630: Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Patent Settlements. Patent Abuse. Accelerating the Patent Dance. BPCIA Patent Dance. H.R.3666: STRONGER Patents Act of 2019. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019. H.R.3812/S.1209: Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act.

Patent Settlements. Patent Abuse. Accelerating the Patent Dance. BPCIA Patent Dance. H.R.3666: STRONGER Patents Act of 2019. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019. H.R.3812/S.1209: Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.

Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.