Medicines regulation in the United States

The national authority

The Food and Drug Administration (FDA) is the United States regulatory authority for drugs, biologics, medical devices, food, cosmetics and tobacco products. It sits within the Department of Health and Human Services. Its drug and biologic work runs mainly through the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER); devices are handled by the Center for Devices and Radiological Health (CDRH).

Its legal base is the Federal Food, Drug, and Cosmetic Act and related statutes.

How products reach the market

New drugs generally reach the market through investigational new drug (IND) applications for clinical testing, followed by a New Drug Application (NDA) or Biologics License Application (BLA). Generic drugs use Abbreviated New Drug Applications (ANDAs). Devices follow risk-based pathways, from registration for low-risk products through premarket notification (510(k)) to premarket approval (PMA) for the highest-risk devices.

Public records and registries

Approved drug products appear in the Orange Book, therapeutic equivalence and patent information included. Device clearances and approvals are searchable in public databases. Clinical trials are registered on ClinicalTrials.gov, and adverse events are collected through FAERS for drugs and MAUDE for devices. Many records are also available through the openFDA data platform.

Using this profile

This is a structural orientation, not legal or regulatory advice. Pathways, user fees and requirements change; anyone acting on a real submission should work from the authority's current guidance or a qualified regulatory professional.