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84 Congressional Research Service reports and publications

Expiring Health Provisions of the 119th Congress
2025-09-24 · Reports · R48649 · HTML available · PDF available
Food and Dietary Supplement Labeling Claims: FDA Regulation and Select Legal Issues
2025-08-12 · Reports · R48623 · HTML available · PDF available
Preterm Infant Formula and Necrotizing Enterocolitis Litigation
2025-08-04 · Posts · IN12591 · HTML available · PDF available
Recent Supreme Court Decisions Related to ECigarette Regulation
2025-07-03 · Posts · LSB11334 · HTML available · PDF available
Pharmaceutical Patent Disputes: Generic Entry for Small-Molecule Drugs Under the Hatch-Waxman Act
2025-06-12 · Resources · IF13028 · HTML available · PDF available
Pharmaceutical Patent Disputes: Biosimilar Entry Under the Biologics Price Competition and Innovation Act (BPCIA)
2025-06-12 · Resources · IF13029 · HTML available · PDF available
District Court Rules FDA Lacks Authority to Regulate Laboratory Developed Tests
2025-05-19 · Posts · LSB11312 · HTML available · PDF available
Finding Medical Device and Drug Approval Information Through the Food and Drug Administration Databases
2025-05-19 · Reports · R48133 · HTML available · PDF available
U.S. Food and Drug Administration (FDA) Regulation of Electronic Nicotine Delivery Systems (ENDS): Background and Selected Policy Issues
2025-04-04 · Reports · R48483 · HTML available · PDF available
NIH Indirect Costs Policy for Research Grants: Recent Developments
2025-03-03 · Posts · IN12516 · HTML available · PDF available
The Vaccine Adverse Events Reporting System: Understanding the Data
2025-01-16 · Posts · IN12486 · HTML available · PDF available
FDA Regulation of Laboratory-Developed Tests (LDTs)
2025-01-14 · Resources · IF11389 · HTML available · PDF available
The National Institutes of Health (NIH): Background and Congressional Issues
2025-01-13 · Reports · R41705 · HTML available · PDF available
Artificial Intelligence (AI) in Health Care
2024-12-30 · Reports · R48319 · HTML available · PDF available
Patent Listing in FDA’s Orange Book
2024-12-27 · Resources · IF12644 · HTML available · PDF available
Cybersecurity and Digital Health Information
2024-12-04 · Resources · IF12591 · HTML available · PDF available
Ultra-Processed Foods (UPF): Background and Policy Issues
2024-11-22 · Resources · IF12826 · HTML available · PDF available
Over-The-Counter Monograph Drug User Fee Program (OMUFA) Reauthorization
2024-11-20 · Resources · IF12821 · HTML available · PDF available
Health Claims on Food and Dietary Supplement Labels: FDA Regulation and Select Legal Issues
2024-10-31 · Resources · IF12801 · HTML available · PDF available
Novel Gene Therapies for Blood Disorders
2024-10-25 · Resources · IF12796 · HTML available · PDF available
FDA Regulation of Tampons
2024-10-11 · Posts · IN12441 · HTML available · PDF available
Legal Effect of Marijuana Rescheduling on FDA’s Regulation of Cannabis
2024-09-16 · Posts · LSB11227 · HTML available · PDF available
Xylazine and the Controlled Substances Act: Legal Considerations for Congress
2024-07-19 · Posts · LSB11202 · HTML available · PDF available
National Institutes of Health (NIH) Funding: FY1996-FY2025
2024-06-25 · Reports · R43341 · HTML available · PDF available
The Federal Status of Marijuana and the Policy Gap with States
2024-05-02 · Resources · IF12270 · HTML available · PDF available
FDA Human Medical Product User Fee Programs
2024-04-26 · Reports · R44750 · HTML available · PDF available
Regulation of Laboratory-Developed Tests: FDA’s Proposed Rule
2024-04-08 · Resources · IF12628 · HTML available · PDF available
Vanda Pharmaceuticals, Inc. v. United States: Fifth Amendment Takings Claims for Alleged Disclosures of Trade Secrets and Confidential Information
2024-04-08 · Posts · LSB11143 · HTML available · PDF available
Circuit Split over the Food and Drug Administration’s Denial of Applications Seeking to Market Flavored E-Cigarettes, Part 1 of 2
2024-04-05 · Posts · LSB11141 · HTML available · PDF available
Circuit Split over the Food and Drug Administration’s Denial of Applications Seeking to Market Flavored E-Cigarettes, Part 2 of 2
2024-04-05 · Posts · LSB11142 · HTML available · PDF available
The Orphan Drug Act: Legal Overview and Policy Considerations
2024-03-05 · Resources · IF12605 · HTML available · PDF available
The Role of Patents and Regulatory Exclusivities in Drug Pricing
2024-01-30 · Reports · R46679 · HTML available · PDF available
Prescription Drug Importation
2024-01-22 · Resources · IF11056 · HTML available · PDF available
Animal Use in Federal Biomedical Research: A Policy Overview
2023-12-28 · Resources · IF12002 · HTML available · PDF available
Expired and Expiring National Institutes of Health (NIH) Provisions
2023-12-06 · Posts · IN12173 · HTML available · PDF available
Kratom Regulation: Federal Status and State Approaches
2023-11-28 · Posts · LSB11082 · HTML available · PDF available
FDA Regulation of Cosmetics and Personal Care Products Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
2023-10-30 · Reports · R47826 · HTML available · PDF available
The Cancer Moonshot: Overview and Issues
2023-09-29 · Resources · IF12504 · HTML available · PDF available
Naloxone for Opioid Overdose: Considerations for Congress
2023-09-11 · Resources · IF12490 · HTML available · PDF available
The Orphan Drug Act and Catalyst Pharmaceuticals, Inc., v. Becerra
2023-08-17 · Reports · R47653 · HTML available · PDF available
PREVENT Pandemics Act (P.L. 117-328, Division FF, Title II)
2023-08-15 · Reports · R47649 · HTML available · PDF available
Xylazine: Considerations for Federal Control
2023-08-01 · Posts · IN12086 · HTML available
Medical Product Regulation: Drugs, Biologics, and Devices
2023-05-26 · Resources · IF11083 · HTML available · PDF available
Advanced Research Projects Agency for Health (ARPA-H): Overview and Selected Issues
2023-05-23 · Reports · R47568 · HTML available · PDF available
FDA Regulation of Medical Devices
2023-01-04 · Reports · R47374 · HTML available · PDF available
The Food and Drug Administration (FDA) Budget: Fact Sheet
2022-12-09 · Reports · R44576 · HTML available · PDF available
Prescription Drug Discount Coupons and Patient Assistance Programs (PAPs)
2022-09-12 · Reports · R44264 · HTML available · PDF available
Infant Formula Shortage: FDA Regulation and Federal Response
2022-05-21 · Resources · IF12123 · HTML available · PDF available
The Evolution of Marijuana as a Controlled Substance and the Federal-State Policy Gap
2022-04-07 · Reports · R44782 · HTML available · PDF available
Synthetic Nicotine: Frequently Asked Questions
2022-02-28 · Reports · R47043 · HTML available · PDF available