AI drug discoverybriefings.

Abstract image of data streams flowing through open gates toward a sealed vault, symbolizing ungoverned data pipelines feeding a regulated endpoint.

AI Drug Discovery's Real Exposure Isn't the Data. It's the Custody Chain No One Regulates Yet

FDA's change control framework governs AI devices after authorization, but the real-world data pipelines feeding discovery-stage models before submission remain ungoverned.

Glowing digital data particles representing AI-driven drug discovery converge on a stone archway symbolizing regulatory evidence requirements.

AI Discovers Drugs. It Doesn't Approve Them.

AI drug discovery has drawn billions in investment but zero FDA approvals, and the bottleneck sponsors need to plan for is evidence, not speed.