The FDA is establishing the Oncology Center of Excellence (OCE) and appointing Dr. Richard Pazdur as its director. This will make oncology the first disease area to have a coordinated clinical review of drugs, biologics and devices across the agency’s three medical product centers.
The FDA is taking important steps to formalize the structure and implementation of the OCE as part of its overarching effort to better address the needs of cancer patients, through reorganization within the FDA’s Office of Medical Products and Tobacco.
While the review criteria and application requirements for medical products, as well as the work of review staff in the centers will not change, uniting experts to collaborate on the clinical review of oncology products will enhance the agency’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.