Richard Pazdur, M.D., has been appointed as the new director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA), according to an announcement from the U.S. Department of Health and Human Services (HHS) and FDA on November 11, 2025. Dr. Pazdur is a longtime member of the FDA, having served for 26 years and previously founding the agency's Oncology Center of Excellence.
During his tenure at FDA, Dr. Pazdur led efforts to improve coordination across different centers for reviewing oncology products, aiming to accelerate development of new cancer treatments. He also oversaw several initiatives that made it easier to approve, access, and update information on oncology drugs. These include Project Orbis, which allows simultaneous submission and review of cancer drugs with international partners; Project Facilitate, which assists healthcare professionals in expanded access requests for patients; and Project Renewal, which updates prescribing information for older cancer drugs to keep them clinically relevant.
“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.”
Prior to joining FDA, Dr. Pazdur was a professor at The University of Texas M.D. Anderson Cancer Center in Houston. He holds degrees from Northwestern University and Loyola Stritch School of Medicine, with clinical training completed at Rush-Presbyterian St. Luke’s Medical Center and University of Chicago Hospitals and Clinics. His academic work includes more than 800 publications.
Dr. Pazdur will remain director of the Oncology Center of Excellence until a replacement is selected.
