CDER professionals participate in several meetings, conferences and workshops throughout the year. Appealing primarily to the pharmaceutical industry and health care professionals, topics can range from users […]

The Patient-Focused Drug Development Program Staff leads initiatives and provides strategic, regulatory, program, and policy assistance within the Center for Drug Evaluation and Research (CDER) to […]

For Immediate Release: June 04, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

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, […]