FDA

U.S. Food and Drug Administration

U.S. regulator for drugs, biologics, devices & combination products.

National agencyUnited StatesSilver Spring, MD, USAEst. 1906Website

Overview Regulatory scope Programs & pathways Guidance & approvals Agency structure

Regulatory scope

Product categories regulated

Small moleculesBiologicsBiosimilarsVaccinesCell therapyGene therapyATMPsMedical devicesCombination productsRadiopharmaceuticalsOther

Submission types

INDNDABLAANDADMFDevice applicationOrphan drug applicationBiosimilar applicationPre-submission meeting

Therapeutic areas

OncologyRare diseasesInfectious diseasesNeurologyImmunologyVaccines

Inspection programs

GMPGDPGLPGCPPharmacovigilanceData integrity

Digital & transparency

Online submission portaleCTD supportedPublic assessment reportsGuidance databaseEnforcement databaseInspection databasePharmacovigilance databaseOpen-data portal

FDA

U.S. Food and Drug Administration

National agency · USA

Live record · illustrative seed data · scores deterministic, rules-based — not AI.