WASHINGTON, April 29 -- Food and Drug Administration has issued a notice called: AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information.
The notice was published in the Federal Register on April 29 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or the Agency) is issuing this request for information 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. Early-phase clinical trials represent a critical bottleneck in drug development, often characterized by high uncer...