The U.S. Food and Drug Administration on September 15, 2026, announced the final design of its Expedited Investigational New Drug Pilot and began accepting applications from drug sponsors paired with qualified research institutions. Applications will remain open through October 30, 2026, and the FDA expects to select 8–10 sponsor-QRI pairs for the initial cohort.
The pilot, part of the U.S. Department of Health and Human Services’ Operation TrialBlazer, is intended to shorten the period between identifying a drug and initiating a first-in-human clinical trial. The FDA said such trials may currently take up to two years to complete in the United States, while comparable trials are completed faster in China and Australia. First-in-human trials are used to determine proper dosing, absorption and other factors relevant to potential approval.
Under the program, selected qualified research institutions will provide specialized scientific expertise during preparation of IND applications. The FDA will be able to review and accept individual components on a rolling basis during the pre-IND phase instead of waiting until every component is available before beginning its review. According to the agency, this approach will test whether potential problems can be identified and resolved earlier, reducing the risk that a first-in-human trial protocol is placed on clinical hold during the 30-day IND period.
The pilot also encourages coordination of activities that may occur alongside IND development and review, including Institutional Review Board review and clinical trial site activation where appropriate. The agency said earlier planning could reduce delays between the start of IND preparation and the opening of first-in-human studies. Acting FDA Commissioner Kyle Diamantas said the program will also test whether sponsor-institution partnerships can accelerate steps taken after the FDA permits a trial to proceed, without compromising patient safety.
The FDA emphasized that it retains full regulatory authority, including responsibility for deciding whether a clinical investigation may proceed and whether a clinical hold should be imposed. Evidence from the pilot may inform future approaches to early-stage clinical development, including a possible formal accreditation model recognizing qualified research institutions that demonstrate strong scientific and regulatory judgment. The agency said its final design incorporates public feedback; detailed eligibility, conflict-of-interest and selection requirements are available on the Expedited IND Pilot webpage, and applications will be reviewed by FDA scientific experts.