FDA expedited IND pilot applications close October 30
FDA is accepting paired applications from drug sponsors and qualified research institutions for its expedited investigational-new-drug pilot through October 30.
What the record says
The pilot is intended to test whether collaboration with research institutions and earlier review of application components can shorten the path to first-in-human trials. FDA expects to select eight to ten sponsor–institution pairs and retains its regulatory oversight.
Source details and supporting locations.
Practical next step
Prospective sponsor and research-institution pairs should review FDA’s eligibility and application instructions before the October 30 deadline.
Limits and what is not established
An application or pilot selection is not drug approval, authorization to begin a trial or a guarantee of a faster review.
Sources checked October 15, 2026. Later notices may change instructions or arrangements.
Original sources
U.S. Food and Drug Administration: original information