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Event
FDA Expedited Investigational New Drug (IND) Pilot Program
FDA
https://www.fda.gov/industry/fda-actions-accelerate-and-modernize-early-and-late-stage-clinical-development/fda-expedited-investigational-new-drug-ind-pilot-program?utm_medium=email&utm_source=govdelivery
09/15/2026 - 10/30/2026
The Expedited Investigational New Drug (IND) Pilot Program is an initiative proposed under the Department of Health and Human Services’ broader Operation TrialBlazer, designed to shorten the time between initial drug identification and first-in-human clinical trials while upholding strict safety standards. The program functions by establishing a network of Qualified Research Institutions (QRIs) to collaborate directly with drug sponsors on developing and reviewing Phase 1 IND submissions. To streamline the pre-IND process and prevent common delays, the FDA is exploring a rolling submission platform. This allows regulators to review completed pharmacology, toxicology, and manufacturing components before the formal IND package is finalized, with the ultimate goal of improving submission quality and minimizing the occurrence of clinical holds. Submission deadline for applicants is 30 October 2026. Please refer to the Applications Instructions at the site link for more details.