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 […]