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FDA Launches Expedited IND Pilot, Begins Accepting Applications
The U.S. Food and Drug Administration today announced the final design of the Expedited Investigational New Drug (IND) Pilot. Accelerating clinical trial timelines and eliminating regulatory hurdles to maintain American leadership in global medical innovation is a core priority for the Trump Administration.
Driven by the President’s directive, the pilot seeks to accelerate the time it takes from identifying a drug to initiating a first-in-human clinical trial by partnering drug companies with qualified research institutions (QRI) that have scientific expertise to support efficient development of IND applications.
Currently, first-in-human clinical trials may take up to two years to complete in the United States. The same types of trials are completed much faster in China and Australia, threatening America’s leadership in scientific innovation. As a key component of the Trump Administration’s healthcare modernization efforts and as part of the U.S. Department of Health and Human Services’ Operation TrialBlazer, the FDA has committed to proactively addressing these clinical development challenges through dedicated initiatives such as the Expedited IND Pilot.
The FDA’s Expedited IND Pilot webpage provides detailed information on program eligibility criteria, conflict of interest requirements, and the selection criteria the agency will use to determine participation. Drug sponsors and prospective QRIs will apply as a pair with drug sponsors submitting applications to the FDA.
The application period will be open until October 30, 2026. Applications will undergo review by FDA scientific experts. FDA expects that 8–10 Sponsor-QRI pairs will be selected to participate in the initial pilot cohort.
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