STAT+: FDA may not always require post-approval trials to be enrolled before accelerated approvals
WASHINGTON — A Food and Drug Administration official on Monday gave more clues for how the agency plans to wield new authority to make drug companies enroll post-market clinical trials before granting speedy drug approvals.
That new power is part of reforms to the FDA’s accelerated approval path that Congress recently passed. Accelerated approvals allow the agency to provide fast access to drugs for serious and life-threatening diseases by approving them based on test results that predict clinical outcomes.
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