Pharma & drug development · Reference
What is the FDA (Food and Drug Administration)?
The FDA (US Food and Drug Administration) is the federal agency that regulates drugs, biologics, medical devices, food and related products. Its role in research is reviewing the evidence behind new medicines and deciding whether they may be marketed.
What the FDA regulates
The FDA’s remit is broad. It oversees prescription and over-the-counter drugs, biologics such as vaccines and cell therapies, medical devices, much of the food supply, cosmetics and tobacco products. Within medicines, specialised centres handle different product types — most small-molecule drugs are reviewed by the Center for Drug Evaluation and Research (CDER), while biologics are reviewed by the Center for Biologics Evaluation and Research (CBER). The agency does not itself develop or sell products; it sets standards, reviews evidence, and authorises or restricts what others may market.
The review and approval role
The FDA’s best-known function is gatekeeping access to the market. A company that wants to sell a new medicine must submit a structured evidence package — generated through preclinical studies and clinical trials run to Good Clinical Practice — and the FDA evaluates whether the benefits outweigh the risks for the proposed use. This is the drug-approval process. The agency also sets manufacturing expectations through Good Manufacturing Practice and continues to monitor products after approval.
After approval: ongoing oversight
FDA oversight does not end at approval. The agency runs pharmacovigilance programmes that collect reports of adverse events once a medicine is in wide use, inspects manufacturing sites for GMP compliance, and can require label changes, restrictions or product recalls if new safety information emerges. Internationally, the FDA is one of the major regulators — alongside the EMA in the EU and the MHRA in the UK — whose decisions influence how medicines are developed and reviewed worldwide.
Key facts
At a glance
- Full name: US Food and Drug Administration
- Type: US federal regulatory agency
- Regulates: Drugs, biologics, devices, food, cosmetics, tobacco
- Drug centre: CDER (drugs); CBER (biologics)
- Core role: Reviews evidence; approves or restricts marketing
- After approval: Safety monitoring, inspection, recalls
Common questions
FAQ
What does the FDA do?+
The FDA regulates the safety and effectiveness of medicines, biologics, medical devices and much of the food supply in the United States. For medicines its central task is reviewing the evidence behind a product and deciding whether it can be marketed. This is an educational overview of a regulatory body, not medical advice.
Does the FDA make drugs?+
No. The FDA does not develop, manufacture or sell medicines. Companies develop products and submit evidence, and the FDA reviews that evidence and sets the standards products must meet.
How does the FDA compare to the EMA and MHRA?+
The FDA is the US regulator, the EMA coordinates evaluation across the European Union, and the MHRA regulates in the United Kingdom. They have similar protective goals and often reference shared ICH standards, but each makes its own marketing decisions for its territory.
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