FDA Opens New Pilot to Speed Up First in Human Drug Trials

The FDA has opened applications for its Expedited Investigational New Drug Pilot, a new program meant to shorten the path between identifying a drug candidate and starting a first in human clinical trial, according to an FDA press announcement. The agency notes that first in human trials in the United States can currently take up to two years, compared with faster timelines in countries like China and Australia.

Under the pilot, drug sponsors will apply jointly with a Qualified Research Institution (QRI) that brings scientific expertise to preparing the IND application. The FDA says this pairing will allow rolling review of application components during the pre IND phase, rather than waiting for a full package, with the goal of catching problems earlier and reducing the chance of a clinical hold once the 30 day IND review period begins.

The FDA emphasizes that it retains full authority to decide whether a trial may proceed or should be placed on hold. This is a process pilot, not a drug approval program: it applies to early administrative and scientific coordination, not to any specific compound, and no product's safety or effectiveness is being evaluated here. The FDA plans to select 8 to 10 sponsor QRI pairs for the initial cohort, with applications open until October 30, 2026.

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