Drug Shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. Manufacturers provide FDA most drug shortage information, and the agency works closely with them to prevent […]

Committee’s Official Designation Gastrointestinal Drugs Advisory Committee Authority The Gastrointestinal Drugs Advisory Committee (the Committee ) is established under 15 U.S.C. 1451 et seq.; 21 U.S.C. […]

The DMF Payments Received table summarizes total monthly counts of GDUFA Type II Active Pharmaceutical Ingredient (API) Drug Master File (DMF) payments according to the month and […]

For Immediate Release: March 01, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

On March 1, 2024, the Food and Drug Administration approved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed for the first-line treatment of locally advanced […]

Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice The emergency […]

Human Compounding Fee Payment Instructions When are fees incurred?Beginning in fiscal year (FY) 2015, outsourcing facilities that register with the FDA may incur one or more […]

Recent New and Generic Drug Approvals 7-day and 14-day reports from Drugs@FDA New Drugs at FDA CDER’s New Molecular Entities and New Therapeutic Biological Products Meetings, […]

Image By: Patrizia Cavazzoni, M.D., Director, Center for Drug Research and Evaluation and Hilary Marston, M.D., M.P.H., Chief Medical Officer Patrizia Cavazzoni, M.D. Each day, many […]