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AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information; Extension of 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 entitled "AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information" that appeared in the Federal Register of April 29, 2026. In the notice, FDA requested comments to solicit input on a proposed pilot program to assess how artificial intelligence (AI)-enabled technologies can improve efficiency, speed, and quality of decision- making in early phase clinical trials. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
- Document type
- Notice
- Federal Register document number
- 2026-10602
- Published
- May 28, 2026
- Action
- Request for information; extension of comment period.
- Docket
- FDA-2026-N-4390
- Comments posted on Regulations.gov (at last check)
- 0
- DATES section (from the document)
- FDA is extending the comment period on the request for information published April 29, 2026 (91 FR 23100). Either electronic or written comments must be submitted by June 29, 2026.
- Topics (auto-tagged)
- Clinical
Source: Federal Register API, document 2026-10602. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.