Getty Images
FDA launches gen AI Elsa to support clinical, regulatory tasks
The FDA is scaling up the rollout of Elsa, an in-house generative AI tool designed to assist with clinical protocol reviews, adverse event summaries and internal data tasks.
The FDA announced it will extend the rollout of its generative artificial intelligence platform, Elsa, agency-wide by June 30, 2025. The agency's internal generative AI tool is intended to assist FDA personnel in performing tasks related to clinical protocol assessments, safety evaluations and internal workflow efficiencies.
Elsa was developed through collaboration between the FDA's internal technology teams and leadership across multiple centers. It operates within a secure GovCloud environment, providing access to internal documents for FDA staff, ranging from scientific reviewers to investigators. According to the agency, Elsa does not train on data submitted by the regulated industry to ensure proprietary information remains confidential.
"Following a very successful pilot program with FDA's scientific reviewers, I set an aggressive timeline to scale AI agency-wide by June 30," FDA Commissioner Marty Makary, M.D., M.P.H. said in an FDA news release. "Today's rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers."
Though Elsa's development has not been officially tied to workforce reductions, its rollout comes as the FDA contends with the loss of 3,500 jobs and a proposed 25% cut to the HHS budget. These reductions place pressure on regulatory operations and could significantly slow down the drug approval process, limit the agency's capacity for routine facility inspections and delay administrative responsiveness.
Elsa's capabilities
Elsa is already in use at the FDA to assist with clinical protocol reviews, reduce time spent on scientific evaluations and identify inspection targets that might warrant priority.
The tool is powered by a large language model that is designed to support various text-based tasks, such as summarizing adverse events for safety assessments, performing faster drug label comparisons and generating programming code for building nonclinical databases.
"Today marks the dawn of the AI era at the FDA with the release of Elsa," FDA Chief AI Officer Jeremy Walsh said. "AI is no longer a distant promise but a dynamic force enhancing and optimizing the performance and potential of every employee."
Elsa's deployment represents the initial phase of the FDA's broader AI integration strategy. Future enhancements and expansions of Elsa's functionalities could include additional AI-driven processes such as advanced data analytics and expanded generative AI applications.
"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 said.
Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.
