FDA Launches Expedited IND Pilot After Incorporating Stakeholder Feedback

The FDA has begun accepting applications for its Expedited Investigational New Drug (IND) Pilot Program, part of HHS’s Operation TrialBlazer. It is intended to shorten the period from identifying a drug candidate to beginning a first-in-human trial while retaining standard safety and scientific-review requirements.

The agency says it revised the pilot after public input. A key change is a less prescriptive definition of a “qualified research institution” (QRI):
institutions may be public or private and need not be academic, provided they can offer meaningful partnership and consultative support to sponsors.

Sponsors must apply jointly with a QRI. FDA expects to select roughly 8–10 sponsor-QRI partnerships; the application deadline is October 30, 2026, with selections anticipated by December 18.

The model uses rolling IND submissions, allowing sponsors to submit pieces of an application over time and receive earlier feedback. FDA’s aim is to improve submission quality and reduce avoidable clinical holds.

FDA leaders stressed that QRIs will not take over regulatory decision-making. Agency review teams will still conduct normal IND reviews, addressing concerns about conflicts of interest or outsourced oversight.

The program also encourages parallel—not sequential—work on IND preparation, institutional-review-board review, and site activation, which FDA believes could reduce operational delays before trial launch.