Lifting the ‘Breakthrough’ Veil: FDA Increases Transparency To Reduce Futile Requests

Case studies demonstrating what kinds of drugs do and don’t qualify for the expedited pathway designation will be presented at an April workshop co-sponsored by the Brookings Institution.

FDA is hoping that greater transparency around the “breakthrough therapy” designation process will reduce the number of time-consuming, frivolous requests it receives for the coveted designation.

Much of the resource drain created by the breakthrough program results from having to evaluate requests for designation that are “not even in the ballpark,” Office of New

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