June 30, 2025 — Washington, D.C. — The U.S. Food and Drug Administration (FDA) has achieved a significant milestone by fully integrating generative artificial intelligence (AI) across all its centers. This move follows a successful pilot program aimed at enhancing the efficiency of scientific reviews and streamlining operations. The agency’s new AI tool, named Elsa, is now operational, assisting FDA employees in various tasks, including clinical protocol reviews, scientific evaluations, and identifying high-priority inspection targets.
Elsa, a large language model–powered AI tool, is designed to help FDA staff by reading, writing, and summarizing data. It can summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications. The tool operates within a secure platform, ensuring that sensitive internal documents remain confidential and are not used for external model training.
The integration of AI is expected to significantly reduce the time required for various tasks, improving the agency’s ability to ensure the safety and effectiveness of medical products. FDA Commissioner Marty Makary emphasized the importance of this advancement, stating, “The opportunity to reduce tasks that once took days to just minutes is too important to delay.”
The agency-wide rollout is being coordinated by Jeremy Walsh, the FDA’s newly appointed Chief AI Officer, and Sridhar Mantha. Walsh previously led enterprise-scale technology deployments across federal health and intelligence agencies, while Mantha recently led the Office of Business Informatics in the Center for Drug Evaluation and Research (CDER).
The FDA’s adoption of AI aligns with broader trends in the healthcare industry, where AI is increasingly being used to enhance efficiency and accuracy. The agency has also issued draft guidance to provide recommendations on the use of AI intended to support regulatory decisions about a drug or biological product’s safety, effectiveness, or quality.
As the FDA continues to embrace AI, it plans to expand Elsa’s capabilities, focusing on improving usability, expanding document integration, and tailoring outputs to center-specific needs, while maintaining strict information security and compliance with FDA policy.
The successful integration of AI across all FDA centers marks a significant step forward in the agency’s efforts to modernize its operations and better serve the American public.
