FDA Launches “Generative AI Tool”

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The Food and Drug Administration (FDA) has launched a “generative AI tool” to “modernize” agency functions.

“Today, the FDA launched Elsa, a generative AI tool designed to help employees—from scientific reviewers to investigators—work more efficiently. This innovative tool modernizes agency functions and leverages AI capabilities to better serve the American people,” the FDA stated.

Elsa will perform the following:

➤ Accelerate clinical protocol reviews
➤ Shorten the time needed for scientific evaluations
➤ Identify high-priority inspections targets
➤ Perform faster label comparisons
➤ Summarize adverse events to support safety profile assessments
➤ 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.

“Today’s rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers,” he added.

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From the FDA:

The introduction of Elsa is the initial step in the FDA’s overall AI journey. As the tool matures, the agency has plans to integrate more AI in different processes, such as data processing and generative-AI functions to further support the FDA’s mission.

Prioritizing efficiency and responsibility, the FDA launched Elsa ahead of schedule using an all-center approach. Leaders and technologists across the agency collaborated, demonstrating the FDA’s ability to transform its operations through AI.

“This is a revolution in public health. We’re building a faster, smarter, and more accountable HHS to Make America Healthy Again. Thank you, @DrMakaryFDA, for your leadership in driving this transformational change,” HHS Secretary Robert F. Kennedy Jr. said.

Per Axios:

The FDA said the technology was built in Amazon Web Services’ GovCloud environment, which is designed to host sensitive government data. It isn’t being trained with proprietary data submitted by drug and device manufacturers, according to a summary shared ahead of the public rollout.

The FDA did not detail specifically what information the model is being trained on, but said it offers a “secure platform for FDA employees to access internal documents.”



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