Posted by Michael Wonder on 19 Jan 2017
Statement from FDA Commissioner announcing FDA Oncology Center of Excellence launch
19 January 2017 - Today the U.S. 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 formalise the structure and implementation of the OCE as part of its overarching effort to better address the needs of cancer patients, through reorganisation 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.
