On this page Introduction Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across […]

[embedded content] Antibiotics are powerful medications that save countless lives every day. But they’re not the answer for every illness. Antibiotics treat only some infections caused […]

On November 15, 2024, the Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute leukemia with a […]

On This Page Listen to the The Need for Artificial Intelligence in Pharmacovigilance and the Emerging Drug Safety Technology Program audio podcast.   Podcast Transcript Dr. Weber: […]

For Immediate Release: November 15, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Next week, […]

On This Page Date: December 13, 2024 Time: 10:00 AM – 5:00 PM ET On December 13, 2024, the U.S. Food and Drug Administration (FDA) is […]

On This Page Date: January 28 – 29, 2025 Day1: Tue, Jan 28 8:30 AM – 4:00 PM ET Day2: Wed, Jan 29 8:30 AM – […]

Docket Number: FDA-2016-D-1605 Issued by: Guidance Issuing Office Office of Inspections and Investigations Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical […]

Docket Number: FDA-2015-D-3638 Issued by: Guidance Issuing Office Office of Inspections and Investigations Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical […]