CAPT Kremzner: Expanded access allows patients to use investigational drugs outside of clinical trials. Hi, I’m Captain Mary Kremzner, and this is Drug Info Rounds, brought to […]

On This Page Date: April 4, 2023 – November 7, 2023 Day1: Tue, Apr 4 9:00 AM – 3:00 PM ET Day2: Tue, Nov 7 9:00 […]

On This Page Date: June 6 – 10, 2022 Time: 8:30 AM – 4:50 PM ET [embedded content] Topics & Presentations Day One Speakers Regulatory Education […]

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, […]