The U.S. Food and Drug Administration (FDA) announced today the launch of Elsa, a generative Artificial Intelligence (AI) tool aimed at helping employees—including scientific reviewers and investigators—work more efficiently. According to the agency, Elsa modernizes FDA functions and leverages AI capabilities to better serve the American public.
“Following a very successful pilot program with FDA’s scientific reviewers, I set an aggressive timeline to scale AI agency-wide by June 30,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Today’s rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers.”
Elsa is built within a high-security GovCloud environment, providing a secure platform for FDA employees to access internal documents while ensuring all information remains within the agency. The FDA emphasized that the models do not train on data submitted by regulated industry, safeguarding the sensitive research and data handled by FDA staff.
“Today marks the dawn of the AI era at the FDA with the release of Elsa, AI is no longer a distant promise but a dynamic force enhancing and optimizing the performance and potential of every employee,” said FDA Chief AI Officer Jeremy Walsh. “As we learn how employees are using the tool, our development team will be able to add capabilities and grow with the needs of employees and the agency.”
The FDA is already using Elsa to accelerate clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high-priority inspection targets. Elsa, which is powered by large language models, assists with reading, writing, and summarizing. The tool can summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications.
The FDA described the introduction of Elsa as the initial step in the agency’s broader AI journey. As the tool develops, the FDA plans to integrate more AI into processes such as data processing and generative-AI functions to further support its mission.
Prioritizing efficiency and responsibility, the FDA launched Elsa ahead of schedule using an all-center approach. Leaders and technologists across the agency collaborated, demonstrating the FDA’s ability to transform its operations through AI.