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U.S. Food and Drug Administration

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About U.S. Food and Drug Administration

The U.S. Food and Drug Administration (FDA) is a federal regulatory agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. It also oversees the safety of the nation’s food supply, cosmetics, and radiation-emitting products. The FDA develops and enforces regulations, conducts inspections, and provides guidance to industry and consumers to promote safe and effective products. It operates nationwide with activities and programs across health, safety, and science, including international programs.

Recent News

Antibacterial Susceptibility Test Interpretive Criteria

Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers

FDA Testing Shows U.S. Infant Formula Is Safe, with Undetectable or Very Low Chemical Contamination

FDA Releases Draft Guidance on Registering Pharmaceuticals for Human Use

Denali Therapeutics Secures FDA Approval for AVLAYAH, First Gene Therapy for Hunter Syndrome

FDA Knocks Back AstraZeneca's Self-Injected Lupus Drug

How Do Recent Actions From FDA Provide Insight to the Agency's Enforcement Posture?

Hospitals Could Earn More for Buying US-Made Drugs, CMS Proposes

FDA Launches Pilot Programme to Boost US Manufacturing

Sandoz Q1 Net Sales Rise 3% to $2.76 Bn, Biosimilars Up 18% and 2026 Guidance Reaffirmed

FDA Says It Explained Issues Early on for Corcept's Rejected Cushing's Syndrome Drug

Infant Formula Recalled because of Contamination with Cereulide

FDA Removes Risk Evaluation and Mitigation Strategy (REMS) Program for the Antipsychotic Drug Clozapine

FDA Warned Corcept of ‘Significant Review Issues’ for Rejected Drug in Early Meetings

Development of Local Anesthetic Drug Products With Prolonged Duration of Effect

Breakthrough Stem Cell Therapy Shows Promise for Parkinson’s Disease

FDA's Proposed Peptide Rule Change Boosts Hims & Hers, Sends Mixed Signals Across Pharma

Influenza Vaccine Effectiveness Lower In Recent Months, Preliminary Data Show

IFAST Diagnostics Bags £5M to Speed up Infection Testing and Tackle Antimicrobial Resistance

REGENXBIO Delay Could Put Denali in Pole Position for Hunter Syndrome Approval

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