A 26-year veteran of the US Food and Drug Administration, Dr. Pazdur is recognized for advancing oncology drug review and regulatory innovation. He also serves as founding director of the agency’s Oncology Center of Excellence, a role he will maintain until a successor is named.

Dr. Pazdur has led several initiatives that modernized the US Food and Drug Administration’s approach to cancer drug regulation. His integrated framework for cross-center coordination accelerated the evaluation of novel therapies and improved access pathways. Notably, he oversaw the creation of Project Orbis, which enables concurrent submission and review of oncology products with international regulatory partners; Project Facilitate, which assists oncology professionals in submitting expanded access requests for patients; and Project Renewal, which updates prescribing information for older oncology drugs to ensure scientific relevance and clinical accuracy.

FDA Commissioner Marty Makary, MD, MPH, described Dr. Pazdur as “a true regulatory innovator” with a proven record of success in streamlining drug approval processes. In accepting the role, Dr. Pazdur stated that he is “honored to lead CDER at a time when the FDA is achieving long-sought regulatory reforms.”

Before his tenure at the FDA, Dr. Pazdur was professor of medicine at The University of Texas M.D. Anderson Cancer Center in Houston. He received his medical degree from Loyola Stritch School of Medicine and completed his clinical training at Rush-Presbyterian St. Luke’s Medical Center and the University of Chicago Hospitals and Clinics. He has written more than 800 scientific works, including two oncology textbooks.

Source: FDA