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Expedited Investigational New Drug Pilot Program; Request for Information; Extension of the Comment Period
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Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice that appeared in the Federal Register of June 24, 2026, to open 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.
- Document type
- Notice
- Federal Register document number
- 2026-14672
- Published
- Jul 21, 2026
- Action
- Notice; request for information; establishment of a public docket; extension of the comment period.
- Docket
- FDA-2026-N-4699
- Comments posted on Regulations.gov (at last check)
- 0
- DATES section (from the document)
- FDA is extending the comment period on the notice published on June 24, 2026 (91 FR 37996). Either electronic or written comments, data, or information must be received by August 24, 2026.
- Topics (auto-tagged)
- Clinical
Source: Federal Register API, document 2026-14672. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.