FDA launches gen AI Elsa to support clinical, regulatory tasks

The FDA announced it will extend the rollout of its generative artificial intelligence platform, Elsa, agency-wide by June 30, 2025. The agency's internal generative AI tool is intended to assist FDA personnel in performing tasks related to clinical protocol assessments, safety evaluations and internal workflow efficiencies.

Elsa was developed through collaboration between the FDA's internal technology teams and leadership across multiple centers. It operates within a secure GovCloud environment, providing access to internal documents for FDA staff, ranging from scientific reviewers to investigators. According to the agency, Elsa does not train on data submitted by the regulated industry to ensure proprietary information remains confidential.

"Following a very successful pilot program with FDA's scientific reviewers, I set an aggressive timeline to scale AI agency-wide by June 30," FDA Commissioner Marty Makary, M.D., M.P.H. said in an FDA news release. "Today's rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers."

Though Elsa's development has not been officially tied to workforce reductions, its rollout comes as the FDA contends with the loss of 3,500 jobs and a proposed 25% cut to the HHS budget. These reductions place pressure on regulatory operations and could significantly slow down the drug approval process, limit the agency's capacity for routine facility inspections and delay administrative responsiveness.