FDA Can Apply Faster Drug Withdrawal Powers Without New Guidance

A 2022 law gives the FDA the power to take ineffective drugs off the market more quickly, even those that went through the accelerated approval process before the law went into effect, the agency said.

The Food and Drug Administration clarified in a statement to Bloomberg Law how and when it can use accelerated approval authorities under the Food and Drug Omnibus Reform Act of 2022, or FDORA (Public Law 117-328).

Congress aimed to make it easier for the FDA to remove a drug if confirmatory studies showed these treatments didn’t actually offer the clinical benefit they were ...