The FDA has launched a real-time review pilot aimed at making clinical-trial oversight faster and more data-driven, starting with oncology studies conducted by AstraZeneca and Amgen. The agency says reviewers will access trial data as it is generated, and will use the pilot to evaluate whether real-time safety monitoring, dose selections, safety-signal detection, and patient recruitment can be improved. The initiative is paired with an open call for input on a broader concept: working with companies that use AI tools to enhance trial conduct and monitoring. The AstraZeneca study will run at the University of Texas MD Anderson Cancer Center and the University of Pennsylvania, while Amgen’s effort is a Phase 1b trial at clinical sites not specified in the briefing. The move matters for sponsors because it targets a persistent industry bottleneck—how quickly regulators can interpret evolving benefit-risk signals—while also putting AI-enabled safety monitoring directly into the review workflow.