The U.S. FDA moved toward real-time clinical-trial review, announcing it will pilot a program that lets agency scientists access trial data as it is generated. The effort builds on proof-of-concept trials run with Amgen and AstraZeneca, and is designed to reduce the lag between data collection and review. The agency said the pilot will support additional functions beyond safety monitoring, including dose selection support, identification of safety signals, and improved patient recruitment. In parallel, FDA is seeking public input on the approach, including how AI-enabled safety monitoring could plug into reviewer workflows. Industry participation is already in place, with FDA identifying specific oncology studies from AstraZeneca and Amgen that will rely on a real-time data platform provided by Paradigm Health. The FDA’s initiative signals a shift from batch submissions toward a more continuous evidence generation-and-review model. Separately, unrelated to the pilot but in the same regulatory orbit, a new U.K. clinical trials overhaul introduced a Combined Review mechanism designed to shorten approvals by bundling ethics and regulatory review into a single application.