News Brief: U.S. FDA Launches AI Tool, Elsa

On June 2, 2025, the U.S. Food and Drug Administration (FDA) officially launched Elsa, a generative artificial intelligence (AI) internal productivity tool. Elsa has already been used in training across the agency by scientists, reviewers and field investigators to support decision-making and streamline critical regulatory processes. The tool is designed to help FDA employees work more efficiently, leveraging AI to better serve U.S. citizens.

Built within Amazon Web Services' secure GovCloud environment, Elsa ensures that all data remains within the agency and is not trained on proprietary information submitted by regulated industries. The tool is already in use, expediting clinical protocol reviews, summarizing adverse events to support drug safety assessments, and identifying high-priority inspection targets.

FDA Commissioner Marty Makary highlighted that the rollout of Elsa was completed ahead of schedule and under budget, attributing this achievement to the collaborative efforts across the Agency's centers. As the FDA continues to integrate AI into its processes, further enhancements to Elsa are planned to meet the evolving needs of the agency and its employees.

"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."