FDA opens expedited IND pathway with rolling pre-IND review

The agency announced today the final design of its Expedited Investigational New Drug (IND) Pilot and opened applications for participation, with a deadline of October 30, 2026. The program operates under Operation TrialBlazer, the US Department of Health and Human Services (HHS) initiative launched in June 2026 to reverse the offshoring of early-phase clinical research.

The core mechanism replaces the conventional model — in which a complete IND application is submitted before any FDA review begins — with a rolling pre-IND review conducted in partnership with qualified research institutions (QRIs). Under the pilot, drug sponsors and prospective QRIs apply as a pair; the FDA will select an initial cohort of 8–10 Sponsor-QRI pairs. Selected QRIs are expected to bring specialized scientific expertise to the IND preparation process, enabling the agency to review and accept individual components as they are completed rather than waiting for a full package. The pilot also encourages parallel coordination of activities such as Institutional Review Board review and clinical trial site activation during IND development, with the aim of reducing delays between IND preparation and the start of first-in-human studies.

The FDA retains full regulatory authority throughout, including the ability to impose clinical holds and determine whether an investigation may proceed.

FDA said first-in-human development in the US can take up to two years, with comparable early-stage trials moving more quickly in markets such as Australia and China. By enabling real-time identification and resolution of IND deficiencies, the pilot is intended to reduce the risk of a clinical hold during the standard 30-day IND review period and shorten the path from IND-enabling work to first-in-human study initiation.

The FDA has indicated the program will generate evidence to inform future approaches to early-stage clinical development, including a potential formal accreditation model that would recognize institutions demonstrating strong scientific and regulatory judgment. That would represent a more durable structural change to how IND support is organized in the US — moving toward a recognized network of institutions rather than ad hoc sponsor-led preparation.

The FDA plans to select and notify an initial cohort of 8–10 Sponsor-QRI pairs by December 18, 2026, although the timeline may vary depending on application volume. The Expedited IND Pilot is one of several regulatory modernization efforts active simultaneously: FDA launched its PreCheck Pilot in February 2026 to accelerate domestic manufacturing facility development, selecting seven initial participants in June, while China's Center for Drug Evaluation separately introduced its PIONEER Program in August 2026 for cell and gene therapy development — underscoring that regulatory acceleration has become a competitive priority across multiple jurisdictions.

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