Califf said 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,” Califf said, “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.”
In addition, Califf said, “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.”