FDA Aims to Approve More Drugs Based on Early Clinical Data

(Reuters) – “The U.S. Food and Drug Administration is aiming to approve drugs based on very early data if the drug shows a possible benefit in terms of survival, the head of the agency told lawmakers at a hearing on Thursday.

Speaking before the House Committee on Energy and Commerce, FDA Commissioner Scott Gottlieb said the agency would approve such drugs quickly and figure out later whether the benefit seen was real or coincidental.

Gottlieb cited the FDA’s ‘accelerated approval’ pathway as a potential blueprint… The new proposal would allow approval in a second cancer based on a single arm study in which all patients receive the experimental treatment. He said the agency plans to issue guidance clarifying the circumstances in which such an approach would be appropriate.”

Here’s the Reuters report as well as a link to FDA Statement: Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Implementing the 21st Century Cures Act: An Update from FDA and NIH”.

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