FDA Launches Pilot Program Aimed at Speeding up Clinical Trial Timelines
- September 18, 2026
- Written by AHLA Legal Staff
The Food and Drug Administration (FDA) is now accepting applications for a new pilot program that will test partnering U.S. research institutions with drug companies as a way to shorten the time from drug identification to first-in-human clinical trials.
The Expediated Investigational New Drug (IND) Pilot Program is part of the Department of Health and Human Services’ Operation Trailblazer, an agency-wide effort to accelerate the drug development timeline and reverse the growing share of early-stage clinical research that has moved overseas.
Under the IND Pilot, drug sponsors partner with “qualified research institutions” (QRIs) such as academic medical centers in developing Phase 1 IND submissions with the goal of minimizing the need for clinical holds by leveraging QRIs' specialized expertise to help identify and resolve issues with an application sooner in the process and by encouraging earlier planning and coordination.
The FDA said the pilot could help inform future policy initiatives like a formal accreditation model.
“The pilot not only pairs industry innovators with top research institutions to accelerate high-quality data being submitted to the FDA, it also tests if the partnership can accelerate what happens after the FDA allows a clinical trial to proceed,” said Acting FDA Commissioner Kyle Diamantas, J.D.
Drug sponsors and prospective QRIs must apply as a pair. Drug sponsors must submit the applications on behalf of the pair to the FDA by October 30. FDA expects to select eight to ten sponsor-QRI pairs as initial participants.