CRS Products

84 Congressional Research Service reports and publications

FDA Regulation of Over-the-Counter (OTC) Drugs: Overview and Issues for Congress
2021-12-10 · Reports · R46985 · HTML available · PDF available
COVID-19 Testing: Frequently Asked Questions
2021-09-16 · Reports · R46481 · HTML available · PDF available
FDA Regulation of Tobacco Products
2021-07-09 · Reports · R45867 · HTML available · PDF available
Frequently Asked Questions About Prescription Drug Pricing and Policy
2021-05-06 · Reports · R44832 · HTML available · PDF available
The Generic Drug User Fee Amendments (GDUFA): Background and Reauthorization
2021-04-29 · Reports · R46778 · HTML available · PDF available
Drug Pricing and Intellectual Property: The Legislative Landscape for the 117th Congress
2021-03-31 · Reports · R46741 · HTML available · PDF available
Expanded Access and Right to Try: Access to Investigational Drugs
2021-03-16 · Reports · R45414 · HTML available · PDF available
Vaccine Safety in the United States: Overview and Considerations for COVID-19 Vaccines
2021-01-29 · Reports · R46593 · HTML available · PDF available
Legal Issues in COVID-19 Vaccine Development and Deployment
2020-11-25 · Reports · R46399 · HTML available · PDF available
Medical Supply Chains and Policy Options: The Data Challenge
2020-09-16 · Resources · IF11648 · HTML available · PDF available
FDA’s Role in the Medical Product Supply Chain and Considerations During COVID-19
2020-09-01 · Reports · R46507 · HTML available · PDF available
The U.S. Blood Supply and the COVID-19 Response: In Brief
2020-08-26 · Reports · R46375 · HTML available · PDF available
Development and Regulation of Medical Countermeasures for COVID-19 (Vaccines, Diagnostics, and Treatments): Frequently Asked Questions
2020-06-25 · Reports · R46427 · HTML available · PDF available
Testing, Testing, (Phase) 1-2-3: Legal Considerations for Clinical Trials of Potential COVID-19 Vaccines
2020-06-02 · Posts · LSB10483 · HTML available · PDF available
Pharmaceutical Patenting Practices: A Legal Overview
2020-06-01 · Resources · IF11561 · HTML available · PDF available
Selected Health Provisions in Title III of the CARES Act (P.L. 116-136)
2020-04-29 · Reports · R46334 · HTML available · PDF available
COVID-19: Legal Considerations for Bringing a New Vaccine to Market
2020-03-24 · Posts · LSB10427 · HTML available · PDF available
FDA Regulation of Cannabidiol (CBD) Consumer Products
2020-02-10 · Resources · IF11250 · HTML available · PDF available
FDA Regulation of Cannabidiol (CBD) Consumer Products: Overview and Considerations for Congress
2020-01-21 · Reports · R46189 · HTML available · PDF available
Federal Regulation of Tobacco: Legal Framework and Issues for the 116th Congress
2019-09-30 · Resources · IF11321 · HTML available · PDF available
Biologics and Biosimilars: Background and Key Issues
2019-06-06 · Reports · R44620 · HTML available · PDF available
Drug Pricing and the Law: Pharmaceutical Patent Disputes
2019-05-17 · Resources · IF11214 · HTML available · PDF available
FDA and Drug Prices: Facilitating Access to Generic Drugs
2019-01-17 · Resources · IF11075 · HTML available · PDF available
Drug Shortages: Causes, FDA Authority, and Policy Options
2018-12-27 · Resources · IF11058 · HTML available · PDF available
The SUPPORT for Patients and Communities Act (P.L. 115-271): Food and Drug Administration and Controlled Substance Provisions
2018-11-15 · Reports · R45405 · HTML available · PDF available
Emergency Use Authorization and FDA’s Related Authorities
2018-08-13 · Resources · IF10745 · HTML available · PDF available
How FDA Approves Drugs and Regulates Their Safety and Effectiveness
2018-05-08 · Reports · R41983 · HTML available · PDF available
Federal “Right-to-Try” Legislation: Legal Considerations
2018-03-30 · Posts · LSB10115 · HTML available · PDF available
Prescription Drug User Fee Act (PDUFA): 2017 Reauthorization as PDUFA VI
2018-03-16 · Reports · R44864 · HTML available · PDF available
FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development
2018-03-16 · Reports · R44810 · HTML available · PDF available
Enforcement of the Food, Drug, and Cosmetic Act: Select Legal Issues
2018-02-09 · Reports · R43609 · HTML available · PDF available
Drug Compounding: FDA Authority and Possible Issues for Congress
2018-01-05 · Reports · R45069 · HTML available · PDF available
Specialty Drugs: Background and Policy Concerns
2015-08-03 · Reports · R44132 · HTML available
The Medical Device Excise Tax: Economic Analysis
2015-06-18 · Reports · R43342 · HTML available