Cures Bill Authorizes 'Intercenter Institutes,' But Will US FDA Create Them?
Agency is still working to get oncology center of excellence off the ground and has other large pending reorganizations that could take precedence.
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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.
US FDA oncology chief celebrates his 20th year at the agency with a frank and wide-ranging podcast interview in which he addresses the next (two) phases of the Oncology Center of Excellence, his ‘think it/do it’ mentality, and whether advisory committees still give good advice.
CDER's OHOP, as well as relevant CBER and CDRH staff, should be folded into OCE, which should have final sign-off on all oncology products, ASCO and Friends of Cancer Research say.