FDA - Food and Drug Administration
11/11/2025 | Press release | Distributed by Public on 11/11/2025 15:34
November 11, 2025 - Longtime FDA Innovator Appointed as Director of Center for Drug Evaluation and Research
For Immediate Release: November 11, 2025
The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) today announced that Richard Pazdur, M.D., has been appointed director of the Center for Drug Evaluation and Research (CDER). Pazdur is a 26-year veteran of the FDA and the founding director of its Oncology Center of Excellence.
A renowned regulatory innovator, Dr. Pazdur developed an integrated approach for cross-center coordination of oncology product review to expedite the development of novel cancer therapies. He also led the agency's launch of a series of initiatives that streamlined oncology drug approvals, access, and labeling: Project Orbis to provide a framework for concurrent submission and review of oncology products among international partners, Project Facilitate to support oncology professionals in completing expanded access requests for cancer patients, and Project Renewal to update the prescribing information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date.
"Dr. Pazdur is a true regulatory innovator who will help guide our broader agenda to modernize the agency and streamline the approval process," said FDA Commissioner Marty Makary, M.D., M.P.H. "He has a track record of success and is an impressive forward-thinking scientist."
"I'm honored to lead CDER at a time when the FDA is achieving long-sought regulatory reforms," said Dr. Pazdur. "I look forward to working closely with Dr. Makary and the medical experts he's assembled to help our country reach its peak in drug development."
Before joining the FDA, Dr. Pazdur was professor of medicine at The University of Texas M.D. Anderson Cancer Center in Houston, Texas. He received his bachelor's degree from Northwestern University, his M.D. from Loyola Stritch School of Medicine, and completed clinical training at Rush-Presbyterian St. Luke's Medical Center and the University of Chicago Hospitals and Clinics. Dr. Pazdur has published more than 800 articles, book chapters, and abstracts, and two medical oncology textbooks.
Dr. Pazdur will continue to serve as director of the Oncology Center of Excellence until a successor is named.
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