Both The U.S. Department of Health and Human Services (HHS) and the FDA announced the appointment of Richard Pazdur, M.D., as director of the Center for Drug Evaluation and Research (CDER).¹

“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.”

Dr. Pazdur is expected to continue his service as director of the Oncology Center of Excellence until a successor is appointed.¹

Why did the FDA and HHS appoint Richard Pazdur as director of CDER?

During his 26 years of service in the FDA, Dr. Pazdur developed an integrated approach for cross-center coordination of oncology product review expediting the development of novel cancer therapies, along with leading the agency's launch of a series of initiatives streamlining oncology drug approvals, and access.¹ Dr. Pazdur also lead the labeling of the following projects.

• Project Orbis, providing a framework for concurrent submission and review of oncology products among international partners.
• Project Facilitate, supporting oncology professionals in completing expanded access requests for cancer patients.
• Project Renewal, updating the prescription information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date.

Prior to his 26 years of service with the FDA, Dr. Pazdur was a 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.¹ Along with his educational background, Dr. Pazdur has published over 800 articles, book chapters, abstracts, and two medical oncology textbooks.

Dr. Pazdur’s statement on being appointed director of CDER

“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.”

What led to Dr. Pazdur’s appointment as director of CDER?

Over the course of 2025, FDA has seen a significant amount of turnover amongst its members, including Geroge Tidmarsh the former head of CBER.

On Friday, October 31, FDA announced that Tidmarsh had been placed on administrative leave, and according to ABC News, Tidmarsh was considering stepping down at that time due to what he described as a “toxic environment” at the agency.

On the heels of FDA’s announcement, conflicting reports began circulating as to the reason for Tidmarsh’s removal from FDA, but according to ABC News, Tidmarsh himself claimed his removal was due to criticizing Vinay Prasad, chief medical and scientific officer at FDA, along with criticizing new regulatory processes at FDA designed to speed up the regulatory process.²

Sources

1. Longtime FDA Innovator Appointed as Director of Center for Drug Evaluation and Research U.S. Food and Drug Administration November 11, 2025 https://www.fda.gov/news-events/press-announcements/longtime-fda-innovator-appointed-director-center-drug-evaluation-and-research
2. FDA's top drug regulator placed on leave, considering resigning, citing 'toxic' environment. ABC News. November 2, 2025. https://abcnews.go.com/Politics/fdas-top-drug-regulator-leave-resigning-citing-toxic/story?id=127119927