The US Food and Drug Administration (FDA) has announced the final design of its Expedited Investigational New Drug (IND) Pilot, an initiative aimed at testing approaches to accelerate the development and initiation of First-in-Human (FIH) clinical trials in the United States while maintaining existing standards for participant safety and scientific oversight. The application deadline for the pilot is October 30, 2026.

The pilot is being implemented under the US Department of Health and Human Services’ Operation TrialBlazer. It will pair drug sponsors with Qualified Research Institutions (QRIs), which can include academic medical centres, healthcare networks, contract research organisations, regulatory advisers and other research organisations with relevant scientific expertise.

Under the programme, QRIs will support sponsors in preparing the nonclinical, clinical and Chemistry, Manufacturing and Controls (CMC) components of FIH IND submissions. The FDA will be able to review individual components on a rolling basis during the pre-IND phase instead of waiting for the complete submission.

The rolling review approach is intended to allow scientific and regulatory issues to be identified and addressed earlier in the development process. The FDA said the pilot will assess whether this can improve submission quality, reduce delays and potentially lower the need for clinical holds or additional information requests when the final IND is submitted.

The programme will also encourage coordination of activities that can take place alongside IND development and FDA review, including Institutional Review Board (IRB) review and clinical trial site activation, where appropriate. This is intended to reduce delays between IND preparation and the start of FIH studies.

The FDA will retain full regulatory authority throughout the pilot. Participation will not change the agency’s statutory or regulatory standards for IND review, safe-to-proceed decisions or clinical trial conduct. Sponsors will remain responsible for their IND submissions and the completeness of their final IND packages.

The pilot is also intended to generate evidence that could inform future approaches to early-stage clinical development. The FDA said the programme could help inform potential future accreditation or certification models for QRIs with demonstrated scientific and regulatory expertise.

Drug sponsors and prospective QRIs will apply as a pair for participation. FDA guidance states that the agency expects to select 8–10 Sponsor-QRI pairs for the initial pilot cohort. Applications will be reviewed by FDA scientific experts.

The FDA has specified that participating sponsors should generally be developing novel products for a Phase 1 FIH IND intended to be conducted in the United States, while QRIs are expected to provide expertise across relevant nonclinical, CMC and clinical disciplines and support trial-startup activities.

The application window opened on September 15, 2026, and will remain open until October 30, 2026. The FDA currently expects to select the initial cohort by December 18, 2026, although the timeline may vary depending on the number of applications received.