Health Law Daily Wrap Up, CLINICAL RESEARCH—NOTICES: FDA solicits input on AI-enabled tech proposed pilot program, (May 1, 2026)

By WK Editorial Staff

The FDA seeks 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.

Early-phase clinical trials represent a critical bottleneck in drug development, often characterized by high uncertainty, limited patient populations, and inefficient decision-making processes. This pilot program aims to explore how advances in AI and data science can improve trial efficiency, enhance safety monitoring, facilitate dose selection decisions, and enable more informed early go/no-go decisions (e.g., a regulatory decision as to whether a Phase 1 study may proceed) while maintaining the FDA’s rigorous scientific and regulatory standards and promoting trustworthy AI systems. The pilot program will be guided by principles aligned with the National Institute of Standards and Technology (NIST) AI Risk Management Framework (AI RMF) (Notice, 91 Fed. Reg. 23100 (Apr. 29, 2026)).

Dates. Either electronic or written comments must be received by May 29, 2026.

FederalRegisterIssuances: Notices FDCActNews ClinicalNews GeneralNews