FDA Request for Input on AI Pilot for Early-Phase Clinical Trials
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
The FDA is asking companies, researchers, and other stakeholders to comment on a proposed pilot program that would test how AI can improve early-phase clinical trials. The agency wants input on where AI could help most, how to measure whether it improves speed, safety, and decision quality, and how to keep the systems trustworthy and fair. This matters for drug developers, biotech firms, tech vendors, investigators, and patient groups involved in Phase 1 and other early studies. Comments are due by May 29, 2026, and anything submitted electronically will be public unless filed as a confidential paper submission.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- FDA launches a request for information on a pilot program using AI in early-phase clinical trials.
- The agency asks stakeholders to suggest trial types, AI use cases, collaboration models, and operating structures for the pilot.
- FDA seeks ideas for measuring efficiency, safety, decision quality, model performance, fairness, and trustworthiness under the NIST AI Risk Management Framework.
Obligations
What this law requires
Anyone submitting comments to FDA on Docket No. FDA-2026-N-4390 must include the docket number in the submission.
Commenters submitting feedback electronically must file it through Regulations.gov and follow the portal’s submission instructions.
Electronic comments must be submitted through Regulations.gov and received by 11:59 p.m. Eastern Time on May 29, 2026.
Commenters must ensure that electronically submitted comments do not include confidential information, including medical information, Social Security numbers, or confidential business information, because electronic submissions will be posted publicly unchanged.
If a commenter wants confidential information to remain nonpublic, the commenter must submit the comment only as a written/paper submission rather than electronically.