The FDA launched Elsa, its first generative AI tool, to streamline reviews and modernize agency workflow across all centers.
In a major step toward modernizing its operations, the U.S. Food and Drug Administration on Monday launched Elsa , a generative artificial intelligence tool, designed to help agency employees, including scientific reviewers and field investigators, work smarter and faster.
Elsa is the regulator’s first large-scale foray into generative AI and is being dubbed as a turning point for the agency.Built in a secure GovCloud environment, the tool gives staff the ability to quickly search and summarize internal documents without compromising sensitive research and data handled by FDA staff.FDA’s AI era beginsMore than a chatbot, the tool also allows FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process.Importantly, the AI models do not train on information submitted by regulated industries, ensuring the confidentiality of proprietary research.“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,” the agency’s Chief AI Officer, Jeremy Walsh, said. “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 agency said it is already using the tool to speed up clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high-priority inspection targets.FDA Commissioner Dr. Marty Makary said the launch came ahead of schedule and under budget due to strong collaboration among internal teams.“Following a very successful pilot program with FDA’s scientific reviewers, I set an aggressive timeline to scale AI agency-wide by June 30,” he said. “Today’s rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers.”Efficiency meets artificial intelligenceElsa is a large language model–powered AI tool designed to assist with reading, writing, and summarizing. It can summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications.It is seen as the first step in a broader strategy to embed AI into FDA workflows.“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,” the agency within the U.S. Department of Health and Human Services said in a release.As employees use the tool, its developers plan to expand capabilities to meet emerging needs. This includes improving usability, data processing, generative-AI functions, and tailoring outputs to center-specific needs while maintaining strict information security and compliance with FDA policy.The agency-wide rollout was coordinated by Walsh, the agency’s newly-appointed Chief AI Officer, and Sridhar Mantha. Walsh previously led enterprise-scale technology deployments across federal health and intelligence agencies, and Mantha recently led the Office of Business Informatics in CDER.
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