Black-box warnings, market withdrawals increased after PDUFA enactment

Over one-quarter of new drugs approved after the enactment of the Prescription Drug User Fee Act were subsequently withdrawn from the market or issued black-box safety warnings, according to a recent study.The authors wrote that the Prescription Drug User Fee Act (PDUFA), which allows drug makers to pay fees to expedite approval, may play a role in these outcomes, possibly due to rushed drug approvals lacking in quality clinical trial evidence.

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