Cures 2.0 Would Mandate More FDA Centers of Excellence But Oncology-Style Funding Gaps Could Doom Plan
The two new intercenter institutes, one to focus on a common group of diseases and the other on rare diseases, appear to be unfunded mandates, which could hinder the agency’s ability to get them up and running.
You may also be interested in...
With a new commissioner expected next year, a restructuring may allow the Oncology Center of Excellence to assume sign-off authority for biologics and devices along with drugs.
Acting FDA Commissioner Janet Woodcock says FDA is interested in establishing new ‘Centers of Excellence’ but the current environment is not the right time to make changes at the agency. Woodcock also talked about where FDA will spend its new pandemic money and its reexamination of accelerated approval drugs in a wide-sweeping conversation with the Alliance for a Stronger FDA.
Center for Drug Evaluation and Research Director says rare disease reviews need multiple specialists, which likely would not fit into a centralized rare disease review group.