US FDA May Create Immunology, Neuroscience Centers Of Excellence
Commissioner Gottlieb says new centers would follow template of Oncology Center of Excellence.
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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.
Number one ask is for congressional pressure to centralize rare disease expertise at the agency, but advocates also are preparing legislation that would mandate the new center.
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.