CDER has established an Exclusivity Board to provide oversight and recommendations regarding exclusivity determinations made by the Center, with a primary focus on clarity and consistency […]

What We Do The Division of Applied Regulatory Science (DARS) moves new science into the FDA regulatory process and addresses emergent regulatory and public health questions. […]

Immediate Office (IO) Iilun C. Murphy, M.D., Director, Office of Generic Drugs (OGD) Darby Kozak, PhD, Deputy Director Kendra Stewart, R.Ph., Pharm.D., Deputy Director for Operations […]

The FDA is conducting a Model-Informed Drug Development (MIDD) Paired Meeting Program that will build on the success of the MIDD Paired Meeting Pilot by continuing […]

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 […]