FDA’s AI Acceleration Agenda: Preparing For Real-Time Trials, AI-Assisted Review, Bayesian Methods, and the New Sponsor Readiness Standard

This article examines how the FDA is moving from a traditional, document-heavy review model toward a more continuous, data-rich, AI-enabled regulatory environment — an approach that aligns with the Department of Health and Human Services’ AI Strategy.  The practical implication is significant. AI should no longer be regarded as a back-office innovation or a data-science experiment disconnected from regulatory strategy. Where AI affects safety monitoring, dose escalation, endpoint assessment