The US Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) has appointed Richard Pazdur, MD, as Director, 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 (CoE).

A regulatory innovator, Dr Pazdur developed an integrated approach for cross-centre coordination of oncology product review to expedite the development of novel cancer therapies. He also led the agency's launch of a series of initiatives that streamlined oncology drug approvals, access, and labelling: Project Orbis to provide 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 and scientifically up to date.

“Dr Pazdur is a true regulatory innovator who will help guide our broader agenda to modernise the agency and streamline the approval process. He has a track record of success and is an impressive forward-thinking scientist,” said Marty Makary, MD, MPH, Commissioner, FDA.

Before joining the FDA, Dr Pazdur was professor of medicine at The University of Texas MD Anderson Cancer Center in Houston, Texas. He received his bachelor’s degree from Northwestern University, his MD 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. He has published over 800 articles, book chapters, and abstracts, and two medical oncology textbooks.

 “I’m honoured to lead CDER at a time when the FDA is achieving long-sought regulatory reforms. 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,” said Dr Pazdur, who will continue to serve as Director of the Oncology Center of Excellence until a successor is named.