Docket Number: FDA-2010-D-0133 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist sponsors planning to conduct studies to […]

Docket Number: FDA-2013-D-0362 Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products This guidance document is […]

About FDA Guidances Guidance documents represent the Agency’s current thinking on a particular subject. They do not create or confer any rights for or on any […]

Docket Number: FDA-2021-D-1128 Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for […]

Sridhar Mantha, M.B.A., M.S., B.Tech.Director, Office of Strategic Programs Sridhar (Sri) Mantha, M.B.A., M.S., B.Tech., serves as Director of CDER’s Office of Strategic Programs (OSP). OSP […]

MUSIC: IN Narrator: Unused medicines can spell many things. RISK, if they’re taken by someone they weren’t prescribed for. HARM, if accidentally taken by a child […]

On This Page Date: November 15, 2024 Time: 9:00 AM – 5:00 PM ET Location: Event Location White Oak Campus: The Great RoomConference Center 10903 New […]

For Immediate Release: July 26, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

7/17/2024 Kaleo, Inc. NDA 201739, AUVI-Q (epinephrine injection, USP), for intramuscular or subcutaneous use None None 1/18/2024 Novartis Pharmaceuticals Corporation NDA 209092KISQALI (ribociclib) tablets, for oral use […]