The FDA announced a pilot effort to collect and review clinical trial data in real time, aiming to reduce delays between trial events and regulatory assessment. The initiative will build on proof-of-concept work in oncology conducted by Amgen and AstraZeneca, and will run through a real-time data platform setup. Separately, the FDA is also looking to the public for input on a potential program to work with companies using AI to improve safety monitoring, dose selection, signal detection, and patient recruitment. The FDA’s approach signals a shift toward more continuous oversight rather than waiting for periodic reporting milestones.