WASHINGTON, D.C. — The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced on November 11, 2025, the appointment of Richard Pazdur, M.D., as the new director of the Center for Drug Evaluation and Research (CDER). This appointment places a recognized regulatory innovator at the helm of the center responsible for assuring the safety, effectiveness, and security of human drugs.

Dr. Pazdur is a 26-year veteran of the FDA and is widely known as the founding director of the agency’s Oncology Center of Excellence. His track record demonstrates a commitment to modernizing review processes, making him, according to FDA Commissioner Marty Makary, M.D., M.P.H., a “true regulatory innovator.”

A History of Streamlining and Reform

Dr. Pazdur has earned a reputation for regulatory innovation by developing an integrated approach designed for cross-center coordination of oncology product review. This approach was specifically aimed at expediting the development of novel cancer therapies.

His leadership has been instrumental in launching several key initiatives that have streamlined oncology drug approvals, access, and labeling:

• Project Orbis: Provides a framework for the concurrent submission and review of oncology products among various international partners.

• Project Facilitate: Supports oncology professionals by assisting them in completing expanded access requests for cancer patients.

• Project Renewal: Updates prescribing information for certain older oncology drugs to ensure that it remains clinically meaningful and scientifically current.

Before joining the FDA, Dr. Pazdur served as a professor of medicine at The University of Texas M.D. Anderson Cancer Center in Houston, Texas. He has also contributed significantly to the scientific literature, having published more than 800 articles, book chapters, and abstracts, in addition to co-authoring two medical oncology textbooks.

Implications for CDER and Future Drug Development

Dr. Pazdur’s appointment is seen by agency leadership as a major step toward achieving broader regulatory goals. Commissioner Makary affirmed that Dr. Pazdur “will help guide our broader agenda to modernize the agency and streamline the approval process,” describing him as “an impressive, forward-thinking scientist.”

For CDER, this leadership transition signals a strong focus on reform and optimization—extending the innovative strategies previously applied to oncology across the entire center.

Dr. Pazdur expressed his enthusiasm for taking on the role, noting that he is honored to lead CDER during a period “when the FDA is achieving long-sought regulatory reforms.” He also emphasized his commitment to helping the country “reach its peak in drug development” by working closely with Commissioner Makary and other FDA experts.

Dr. Pazdur will continue to serve as director of the Oncology Center of Excellence until the FDA names a successor.