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Richard Pazdur to help guide CDER agenda to modernize the agency and streamline the approval process.
November 13, 2025
By: Kristin Brooks
Managing Editor, Contract Pharma
The U.S. Department of Health and Human Services (HHS) and the U.S. FDA, has appointed Richard Pazdur, M.D., as 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.
Dr. Pazdur developed an integrated approach for cross-center coordination of oncology product review to help expedite the development of cancer therapies. He also led a series of initiatives that helped to streamline oncology drug approvals, access, and labeling:
Project Orbis provides 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 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. Dr. Pazdur has published more than 800 articles, book chapters, and abstracts, and two medical oncology textbooks.
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