The FDA launched Elsa, a generative AI tool designed to help employees, including scientific reviewers and investigators, work more efficiently.
In a statement, the agency said the tool “modernizes agency functions and leverages AI capabilities to serve the American people better.”
Constructed in a high-security government cloud environment, Elsa provides a platform for FDA employees to access internal documents, while ensuring that all information stays within the agency.
According to the FDA, the models do not train on data submitted by regulated industries, which protects sensitive research and data managed by FDA staff.
The agency is currently using Elsa to expedite clinical protocol reviews, reduce the time required for scientific evaluations and identify high-priority inspection targets.
The FDA describes Elsa as a “large language model, powered AI tool designed to assist with reading, writing and summarizing.”
For example, it can summarize adverse events to support safety profile assessments, perform quicker label comparisons and generate code to help develop databases for nonclinical applications.
“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 Dr. Marty Makary said in a statement.
“Today’s rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers.”
FDA Chief AI Officer Jeremy Walsh noted that the release of Elsa marks the dawn of the AI era.
“AI is no longer a distant promise but a dynamic force enhancing and optimizing the performance and potential of every employee,” Walsh said in a statement.
Walsh added, “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.”
THE LARGER TREND
Department of Health and Human Services Secretary Robert F. Kennedy Jr. recently told a House Appropriations Committee that he wants to “do more with less” with the help of artificial intelligence.
“The AI revolution has arrived and we are already using these new technologies to manage healthcare data more efficiently and securely,” Kennedy told the committee.
Kennedy said he is looking to “transform” the department into a “central hub for AI.”
