FDA’s AI push faces uncertainty after key leaders depart

The FDA has been pushing artificial intelligence across the agency, unveiling a large-language-model tool called Elsa to help draft and summarize review reports and announcing plans to use agentic AI for pre-market reviews, inspections and administrative work.

Recent departures of former commissioner Marty Makary, chief artificial intelligence officer Jeremy Walsh and acting chief information officer Sridhar Mantha have introduced uncertainty about who will steer the AI strategy and how governance will be structured.

Acting commissioner Kyle Diamantas reiterated that AI remains a top priority for the FDA, but the leadership changes may slow the rollout and alter the path of the agency’s AI integration.