WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced the official launch of Elsa, a cutting-edge generative Artificial Intelligence (AI) tool designed to optimize efficiency across the agency. This pivotal step reflects the FDA’s commitment to leveraging advanced technology to strengthen its operations and better serve public health.
Unveiled on June 2, 2025, Elsa, which functions within a highly secure GovCloud environment, marks the beginning of the agency’s broader integration of AI into its processes. According to FDA Commissioner Dr. Marty Makary, the rollout of Elsa is both ahead of schedule and under budget, following a successful pilot program with the agency’s scientific reviewers.
“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 Dr. Makary. “Today’s rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers.”
Enhancing Efficiency with Generative AI
Elsa is a large language model-powered AI tool designed to assist FDA employees in tasks such as reading, writing, summarizing, and data processing. The tool has already been employed to streamline critical functions like clinical protocol reviews, scientific evaluations, and inspection prioritization.
Some of Elsa’s key capabilities include summarizing adverse events to support safety assessments, performing faster label comparisons, and generating code to aid in database development for nonclinical applications. By reducing timeframes for these tasks, Elsa allows employees to focus on higher-priority objectives, directly benefiting the agency’s mission.
FDA Chief AI Officer Jeremy Walsh emphasized the significance of Elsa’s deployment, stating, “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.”
Safeguarding Security and Privacy
Built to ensure the protection of sensitive information, Elsa’s operation is entirely confined to the FDA’s internal systems. The platform ensures that data submitted by regulated industries remains secure and is not used to train the AI models. This stringent focus on security underscores the FDA’s responsibility in handling sensitive public health and industry data.
The Path Ahead
The launch of Elsa represents the first step in the FDA’s broader adoption of AI technologies. The agency plans to expand the tool’s capabilities further, integrating AI into additional processes. Over time, this initiative will likely involve more advanced generative AI features and greater application across the FDA’s operational landscape.
“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,” Walsh noted.
By harnessing AI, the agency aims to improve efficiency and enhance its capacity to fulfill its regulatory responsibilities.
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