FDA formalizes one pivotal trial policy via NEJM perspective

Zachary Brennan / endpoints - Top FDA officials said that a single pivotal trial requirement will be the “new default standard” for drug approvals, a move that goes beyond the agency’s prior discretion around not requiring two trials. In a ...

AI Summary: The FDA has moved to make a single pivotal trial the new default for drug approvals, abandoning the long-standing two-study standard to speed access and ease OTC transitions. The policy, outlined by agency leaders and discussed in a NEJM perspective, raises questions about evidence thresholds and downstream safety monitoring. Welcome to faster approvals — now let's hope that lone study behaves.

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