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Expedited Investigational New Drug Pilot Program; Request for Information
Read on FederalRegister.gov · Official PDF · Docket on Regulations.gov · Add to calendar (.ics)
Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA or the Agency) is opening a public docket to solicit input and comments on a proposal to establish a pilot program, the Expedited Investigational New Drug (IND) pilot program, to shorten the time it takes from drug identification to first-in-human (FIH) study, while protecting clinical trial participants. FDA is requesting information on the potential pilot program which would establish a network of qualified research institutions, such as academic medical centers (AMCs), healthcare networks (HNs), contract research organizations (CROs), regulatory advisors, and/or other research or third-party review organizations (collectively called Qualified Research Institutions, or "QRIs"), who would partner with sponsors to develop and review protocols for FIH clinical trials intended for a IND submission to FDA. Information provided through this public docket will help the Agency refine our approach and consider other opportunities to accelerate time to FIH clinical trials.
- Document type
- Notice
- Federal Register document number
- 2026-12621
- Published
- Jun 24, 2026
- Action
- Notice; request for information; establishment of a public docket.
- Docket
- FDA-2026-N-4699
- Comments posted on Regulations.gov (at last check)
- 217
- DATES section (from the document)
- Either electronic or written comments, data, or information must be received by July 22, 2026.
- Topics (auto-tagged)
- Clinical
Source: Federal Register API, document 2026-12621. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.