FDA Approval
The process by which the U.S. Food and Drug Administration evaluates a drug's safety and efficacy through clinical trial data before allowing it to be marketed.
How It Works
FDA approval requires manufacturers to submit a New Drug Application (NDA) for small-molecule drugs or a Biologics License Application (BLA) for biologics. The application must include data from Phase I (safety), Phase II (efficacy), and Phase III (large-scale confirmatory) clinical trials. The FDA also reviews manufacturing processes, labeling, and risk management plans. Approval timelines vary: standard review takes about 10 months, while priority review takes 6 months. Accelerated pathways exist for drugs treating serious conditions with unmet medical need.
Related Terms
- Generic Drug — A medication that contains the same active ingredient, dosage, and form as a brand-name drug, approved after the original's patent expires — typically costing 80-95% less.
- Biologic Drug — A complex medication derived from living cells — including monoclonal antibodies, vaccines, and cell therapies — that treats serious conditions like cancer and autoimmune diseases.
- Abbreviated New Drug Application (ANDA) — The FDA application pathway for generic drugs, which requires proving bioequivalence to the brand-name drug rather than repeating full clinical trials.
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About This Definition
This definition is part of the DrugPrice Drug Pricing Glossary — 34 terms explaining how prescription drug pricing works in the United States. All definitions are written in plain language for patients, caregivers, journalists, and healthcare professionals.