2026-10602
AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information; Extension of Comment Period (HHS — Notice)
United States · HHS 2026-10602
- Status
- Proposed / pending
- Applies to
- See Federal Register notice — auto-imported, specifics pending verification.
- Enforced by
- HHS
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 p
Who is protected: See Federal Register notice — auto-imported, specifics pending verification.
Legal detail
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.
Key facts
| Jurisdiction | United States |
|---|---|
| Level | Federal |
| Enacted | May 28, 2026 |
| Citation | HHS 2026-10602 |
| Topics | automated decision-making |
| Agency page | Federal Register — HHS — 2026-10602 |
More AI rules in United States
- Trump AI Innovation & Security EO (June 2026) · In effect
- FERC order directing PJM and other grid operators to reform tariffs on… · Enacted (not yet in effect)
- Chatrie v. United States (Fourth Amendment protection for location… · Blocked / in litigation
- Kids Internet and Digital Safety Act (KIDS Act) (H.R. 7757) · Proposed / pending
- NAIC AI Evaluation Tool Pilot (12 states, 2026) · Proposed / pending
- FTC Proposed Policy Statement — AI Accuracy (July 2026) · Proposed / pending
Related automated decision-making rules elsewhere
- CA EO N-6-26 (AI Workforce) · In effect
- Arkansas public entity AI/ADS policy mandate (Act 848, 2025) · In effect
- Connecticut algorithmic rent ban — HB 8002 (eff. Jan 1, 2026) · In effect
- San Diego algorithmic rent price-fixing ban (Ord. O-21955, May 2025) · In effect
- Minneapolis algorithmic rent ban (Ord. 2025-010, eff. Mar 1, 2026) · In effect
- Seattle algorithmic rent-fixing ban (Ord. 127241 / SMC 7.34, July 2025) · In effect
See something wrong or out of date? Submit a correction. Every entry must carry a verifiable source.