FDA Opens Expedited IND Pilot to Speed First-in-Human Trials, Applications Accepted Through Oct. 30

The U.S. Food and Drug Administration announced the final design of an Expedited IND Pilot aimed at shortening the time from drug discovery to first-in-human trials.

The pilot pairs drug developers with qualified research institutions that have scientific expertise to streamline IND applications, seeking to cut the typical two-year timeline for first-in-human studies in the United States.

Applications to join the pilot are being accepted through Oct. 30, 2026, as part of the administration's Operation TrialBlazer initiative to preserve U.S. leadership in medical innovation.