FDA establishes new Oncology Center of Excellence
Established to create a coordinated clinical review of drugs, biologics and devices across the FDA's three medical centers, steps are now being taken to formalize the structure and implementation of the new center. The Oncology Center of Excellence will better address the needs of cancer patients through its reorganization within the FDA’s Office of Medical Products and Tobacco.
The review criteria and application requirements for medical products as well as the day to day work of review staff in the centers will not be changing. The goal is to unite experts to collaborate on the clinical review of oncology products and enhance the FDA’s work in approving safe and effective cancer products.
“In addition, the FDA’s Oncology Center of Excellence will improve the agency’s ability to advance oncology-related regulatory science and policy and streamline stakeholder engagement,” a news release said.
Pazdur previously served as director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. He will continue to serve as acting director.
Prior to joining the FDA, Pazdur was a professor of medicine at The University of Texas M.D. Anderson Cancer Center.