The US Food and Drug Administration (FDA) has launched Elsa, a generative artificial intelligence (AI) tool designed to help employees—from scientific reviewers to investigators—work more efficiently.  

“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., in a June 2, 2025, press statement” “Today’s rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers.” 

Built within a high-security GovCloud environment, FDA says Elsa offers a secure platform for FDA employees to access internal documents while ensuring all information remains within the agency. The models do not train on data submitted by regulated industry, safeguarding the sensitive research and data handled by FDA staff, according to the agency.  

The agency says it is already using Elsa to accelerate clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high-priority inspection targets. Elsa is a large language model–powered AI tool designed to assist with reading, writing, and summarizing. Some examples are how it will be used across the agency to improve operational efficiency are summarizing adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications.  

The introduction of Elsa is the initial step in the FDA’s overall AI implementation. As the tool matures, the agency has plans to integrate more AI in different processes, such as data processing and generative-AI functions to further support the FDA’s  functions.  

Source: US Food and Drug Administration