Food and Drug Administration (FDA)

Key facts

Parent department

U.S. Department of Health and Human Services (HHS)

Core statute

Federal Food, Drug, and Cosmetic Act of 1938, as amended

Regulations

Title 21 of the Code of Federal Regulations (21 CFR)

Drug and biologic centers

CDER (drugs, therapeutic proteins) and CBER (vaccines, blood, gene therapy)

Headquarters

White Oak campus, Silver Spring, Maryland

What is the FDA?

The FDA is a public health regulator. For medical products, it decides whether a drug, biologic or device may be marketed in the United States, sets rules for how products are tested, manufactured and labeled, and monitors safety after products reach patients. Its authority traces back to the Pure Food and Drugs Act of 1906 and the Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938.

The 1938 law required proof of safety before a new drug could be sold. The Kefauver-Harris Amendments of 1962 added the requirement that drugs also be shown effective, which is still the core standard behind every New Drug Application (NDA).

The FDA does not set or negotiate drug prices, does not regulate the practice of medicine and does not approve dietary supplements before they are sold. Physicians may legally prescribe a drug for an unapproved use, while manufacturers face strict limits on promoting such uses.

How the FDA is organized

Product review is split among centers, each with its own offices, databases and review staff:

• Center for Drug Evaluation and Research (CDER): prescription and over-the-counter drugs, generics, and most therapeutic biologics such as monoclonal antibodies.
• Center for Biologics Evaluation and Research (CBER): vaccines, blood products, allergenics, and cell and gene therapies.
• Center for Devices and Radiological Health (CDRH): medical devices, in vitro diagnostics and radiation-emitting products.
• Other units cover human foods, veterinary medicine and tobacco products, plus cross-cutting groups such as the Oncology Center of Excellence.

Why the FDA matters

Nearly every public U.S. drug dataset starts with an FDA action. Approvals feed Drugs@FDA, patents and exclusivities feed the Orange Book and Purple Book, drug listings produce National Drug Codes (NDCs), and safety actions produce recalls, shortage notices and adverse event reports in FAERS.

For commercial and market access teams, FDA milestones drive forecasts. An approval starts a launch, a review goal date signals when a decision is due, and a generic or biosimilar approval signals price erosion. User fee laws renewed every five years, including the Prescription Drug User Fee Act (PDUFA) and the Generic Drug User Fee Amendments (GDUFA), fund much of the review work and set those goal dates.