FDA extends comment period on AI-enabled early-phase clinical trials pilot program request for information
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Summary
The Food and Drug Administration extended the comment period for its request for information on a proposed pilot program to assess how artificial intelligence-enabled technologies can improve efficiency, speed, and quality of decision-making in early phase clinical trials. The original notice appeared in the Federal Register of April 29, 2026 with a 30 days comment period. The agency states it received a request for a 30 days extension and is extending the period until June 29, 2026. Comments may be submitted electronically through the Federal eRulemaking Portal or as written submissions to the Dockets Management Staff, and must reference the docket number. Late comments will not be considered.
Why it matters
Interested persons, including those in clinical research and AI technology, get additional time to give input on a proposed the Food and Drug Administration pilot program for AI use in early phase clinical trials. The document states comments must be received by June 29, 2026.
- Parties involved
- Food and Drug Administration; Department of Health and Human Services
- Federal Register doc. no.
- 2026-10602
- Citation
- 91 FR 31725
- Docket number
- FDA-2026-N-4390
- Primary source
- Federal Register (US) (federalregister.gov)
Source retrieved: . Sources are often in other languages; links open the original. - Topics
- Healthcare & medical AI · General AI governance