United States
Food and Drug Administration (FDA) · Americas
Executive summary
The United States is the world's largest pharmaceutical market and operates an independent, non-reliance regulatory system administered by the Food and Drug Administration (FDA). Marketing authorisation is granted under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, with new chemical entities reviewed under New Drug Applications (NDA) and biologics under Biologics License Applications (BLA). FDA does not formally rely on foreign regulator decisions but accepts foreign clinical data conducted under ICH-GCP. User fees set under the Prescription Drug User Fee Act (PDUFA VII, FY2023–2027) and the Generic Drug User Fee Amendments (GDUFA III, FY2023–2027) drive the majority of CDER's review budget and underpin formal review-clock commitments — 10 months for standard NDAs, 6 months for priority review. The post-approval landscape is shaped by the Drug Supply Chain Security Act (DSCSA), in full enforcement since November 2024, which mandates electronic, interoperable, item-level traceability of prescription drugs. The Inflation Reduction Act (2022) introduced direct Medicare price negotiation for selected high-spend drugs, fundamentally changing the US pricing dynamic for branded medicines.
About the authority
The FDA is an agency of the US Department of Health and Human Services. Drug review is conducted by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER); biological products other than blood, vaccines, allergenics, and cell/gene therapies are reviewed by CDER following the 2003 transfer. The Office of Generic Drugs (within CDER) reviews ANDAs. FDA does not operate a reliance pathway but does accept foreign-generated data and conducts joint inspections under MRAs with the EU, UK, Switzerland, and others.
Reliance & recognition
FDA does not operate a formal reliance pathway. Foreign approval status is not a determinant of FDA review. However, foreign clinical data conducted under ICH-GCP is routinely accepted, and FDA participates in joint reviews under Project Orbis (oncology) and the Access Consortium for selected products. Mutual Recognition Agreements with the EU (since 2017) and UK (since 2024) enable acceptance of GMP inspection outcomes.