When you, the health care professional, voluntarily report observed or suspected adverse events to FDA’s MedWatch program, you provide a vital source of information to FDA. […]

On This Page Date: June 5 – 9, 2023 Time: 8:40 AM – 4:30 PM ET Topics & Presentations Day 1 Speakers REdI Annual Conference 2023 […]

AUTHORITY The Psychopharmacologic Drugs Advisory Committee (the Committee) is established under 15 U.S.C. 1451 et seq.; 21 U.S.C. 321, 341, 342, 343, 343-1, 344, 345, 346, […]

Image By: Richard Pazdur, MD, Director, Oncology Center of Excellence (OCE), and Rea Blakey, Associate Director for External Outreach and Engagement, OCE  If you’ve ever heard […]

Committee’s Official Designation Peripheral and Central Nervous System Drugs Advisory Committee Authority The Peripheral and Central Nervous System Drugs Advisory Committee (the Committee) is established under […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

Facilities may request a certificate of pharmaceutical product or CGMP declaration using the CDER export certification and tracking system (CDEReCATS). CDEReCATS offers several benefits, including a possible […]

On This Page Date: June 3 – 5, 2024 Day1: Mon, Jun 3 9:00 AM – 6:00 PM ET Day2: Tue, Jun 4 9:00 AM – […]

For Immediate Release: May 31, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]