Health and Human Services Department Docket FDA-2026-N-4699 Notice

2026-14672: Expedited Investigational New Drug Pilot Program; Request for Information; Extension of the Comment Period

Comment Period Closed

Public comment closed .

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Summary

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.

The agency’s own summary, as published.

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