FDA Launches Oncology Center For Excellence
By Clinical Informatics News Staff
January 19, 2017 | Even as rumors and speculation swirl around the new head of FDA under President Trump, the U.S. Food and Drug Administration announced today that it is establishing the Oncology Center of Excellence (OCE) and appointing Dr. Richard Pazdur as its director.
The Center of Excellence 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, according to the FDA statement attributed to outgoing FDA Commissioner Robert Califf. The OCE will improve the agency’s ability to advance oncology-related regulatory science and policy and streamline stakeholder engagement, he continued.
The OCE’s structure and implementation is part of FDA’s 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,” Califf wrote.
