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

2026-13592: Expedited Investigational New Drug Pilot Program; Request for Information; Correction

Get alerted when the next rule lands

New rules open for comment on their own schedule. Pick how you want to hear about them — we email you when one appears.

Publishing to members? Embed a live rule tracker on your own site — the proposed rules in your area and the comment deadlines closing on them, updating themselves. Free, one line of HTML.

Create a free account & build one →

Summary

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 24, 2026. That notice opened a public docket to solicit input and comments on a proposal to establish a pilot program, the Expedited Investigational New Drug pilot program, to shorten the time it takes from drug identification to first-in-human study, while protecting clinical trial participants. FDA is correcting the email address of the document.

The agency’s own summary, as published.

Don't miss the comment window

One Click Politics alerts you on every deadline, hearing, and rule change.

See all rules with comments due soon →