Elsa — the FDA's Agency-Wide Generative-AI Tool for Scientific Reviewers

The FDA's Office of the Commissioner uses generative AI to help scientific reviewers process consumer complaints, adverse events and applications for products under its authority faster, through an internal assistant branded "Elsa."
FDA Commissioner Marty Makary said he was "blown away" by results from the agency's first AI-assisted scientific review pilot, citing a case where one reviewer's task fell from about two days to about six minutes; the FDA then set an aggressive timeline to roll Elsa out agency-wide across all FDA centers.
Independent trade-press reporting on Elsa's use found accuracy problems, including the tool generating hallucinated citations and even fabricated studies, with FDA staff describing it as unreliable when queried about basic, publicly available information on approved products.
Because of these limitations, Elsa is explicitly excluded from formal regulatory assessments, and reporters found it unclear how the FDA defines "success" for the tool or what guardrails prevent AI-generated errors from influencing regulatory decisions — a gap between the celebratory rollout announcement and the tool's documented reliability.

Read the full analysis: https://www.medicaleconomics.com/view/fda-s-new-ai-tool-elsa-faces-accuracy-concerns-despite-commissioner-s-high-hopes

Read the full analysis: https://www.fda.gov/news-events/press-announcements/fda-announces-completion-first-ai-assisted-scientific-review-pilot-and-aggressive-agency-wide-ai