Product: Drugs Recipient: Recipient Name Mr. Sandeep Kumar Recipient Title Vice President – Quality Natco Pharma Limited Pharma Division, Kothur VillageRangareddy 509228TelanganaIndia Issuing Office: Center for […]

Docket Number: FDA-2025-D-3023 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research The Food and Drug Administration (FDA […]

MedWatch, the FDA’s medical product safety reporting program for health professionals, patients and consumers.   Report a Problem   Safety Information   Stay Informed MedWatch receives reports from the public and […]

Action The U.S. Food and Drug Administration (FDA) approved Palsonify (paltusotine) tablets to treat adults with acromegaly who have had an inadequate response to surgery and/or for […]

Image By: George Tidmarsh, M.D., Ph.D., Director, Center for Drug Evaluation and Research Clinical trial transparency is fundamental to maintaining public trust in medical research and […]

Voluntary Reporting For use by Health Professionals, Consumers, and Patients Reporting can be done through our online reporting portal or by downloading, completing and then submitting […]

Speech by Sara Brenner, M.D., M.P.H. Principal Deputy Commissioner – Office of the Commissioner Good morning, and thank you for being here. At FDA, our work […]

The Prescription Drug User Fee Act of 1992 (PDUFA), Biosimilar User Fee Act of 2012 (BsUFA), and Generic Drug User Fee Amendments of 2012 (GDUFA) authorize […]

On September 25, 2025, the Food and Drug Administration approved imlunestrant (Inluriyo, Eli Lilly and Company), an estrogen receptor antagonist, for adults with estrogen receptor (ER)-positive, […]