In a significant move toward digital transformation, on 02 Jun 2025 the U.S. Food and Drug Administration (FDA) unveiled a new generative AI tool named Elsa, designed to enhance operational efficiency across the agency, including streamlining scientific reviews.
FDA Commissioner Marty Makary praised the early and cost-effective rollout, stating, “Today’s rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centres.”
Elsa is already being used to accelerate clinical protocol reviews, reduce the time required for scientific evaluations, and help identify high-priority inspection targets. This tool assists FDA reviewers by summarizing adverse events, evaluating safety profiles, and rapidly comparing drug packaging inserts—key tasks in the regulatory decision-making process.
With drug approval timelines ranging from six to ten months, tools like Elsa are expected to play a pivotal role in supporting timely and thorough reviews. Importantly, Elsa operates within a secure FDA environment and does not train on industry-submitted data, ensuring the protection of confidential research information.
Following a successful experimental phase, the FDA confirmed in May that it would fully integrate AI across its operations by June 30. Elsa marks a major step in that direction, signaling the agency’s commitment to embracing innovation while maintaining high standards of regulatory oversight.
