AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information; Extension of Comment Period (HHS — Notice)
United States · HHS 2026-10602
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
Technical 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.
Who is protected: See Federal Register notice — auto-imported, specifics pending verification.
Who must comply: See Federal Register notice — auto-imported, specifics pending verification.
Key facts
| Jurisdiction | United States |
|---|---|
| Level | Federal |
| Status | Proposed / pending |
| Protection strength | Limited protection |
| Enacted | 2026-05-28 |
| Citation | HHS 2026-10602 |
| Enforced by | HHS |
| Topics | automated decision-making |
| Last verified | 2026-06-29 |
| Official source | Federal Register — HHS — 2026-10602 ↗ |
More AI rules in United States
- FTC Act Section 5 (unfair/deceptive AI) · In effect
- TAKE IT DOWN Act · In effect
- FCRA (AI in credit & background checks) · In effect
- ECOA / Regulation B (AI credit discrimination) · In effect
- Title VII / ADA (AI hiring) · In effect
- COPPA + 2025 Rule (childrens data) · In effect
Related automated decision-making rules elsewhere
- CCPA/CPRA + ADMT Regulations · In effect
- Colorado AI Act (repealed) · Repealed / replaced
- SB 26-189 (Colorado ADMT Law) · Enacted (not yet in effect)
- AI Video Interview Act · In effect
- HB 3773 (AI Employment Discrimination) · In effect
- TRAIGA · In effect
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