FDA launches agency-wide AI tool ‘Elsa’ ahead of schedule

The US Food and Drug Administration (FDA) has launched a new artificial intelligence (AI) tool nearly one month ahead of schedule that the agency says significantly improves operations and is aimed at modernizing its functions. The agency said that it will continue to add capabilities based on staff feedback.

On 2 June, FDA Commissioner Marty Makary announced the launch of the agency’s new AI tool, Elsa. The agency had initially planned on rolling out the tool on 30 June, but the commissioner said they were able to successfully test Elsa in a pilot program with scientific reviewers well ahead of schedule and under budget. (RELATED: FDA plans to roll out AI agency-wide for reviews in June, Regulatory Focus 8 May 2025)

“The agency is using Elsa to expedite clinical protocol reviews and reduce the overall time to complete scientific reviews,” said Makary in a video announcement. “One scientific reviewer told me, what took him two to three days, now takes six minutes.”

“Some of the other ways the staff have already told me how they love using the AI tool include summarizing adverse events to support safety profile assessments, conducting expedited label comparisons, and generating code to facilitate the development of databases of nonclinical applications,” he added. “We're also using AI to help inspectors identify high-yield inspection targets.”

FDA Chief AI Officer Jeremy Walsh said the agency's development team will be able to add more capabilities to Elsa and grow based on staff feedback.

"Elsa is a large language model–powered AI tool designed to assist with reading, writing, and summarizing," said FDA in a press release. "It can summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications."

"The introduction of Elsa is the initial step in the FDA’s overall AI journey," the agency added. "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."

Makary noted that he is commonly asked about Elsa's security. He said that all information in Elsa stays in the agency, and the AI models are not trained on data submitted by the medical industry. He also noted that its launch was the first of many AI initiatives the agency is leveraging to serve the American public.

Before making it public, Makary also sent an agency-wide email to staff announcing the AI tool, in which he echoed many of the same points about Elsa.

“Built within a high-security GovCloud environment, Elsa provides a secure platform for employees to interact with internal documents while ensuring that all information remains within our agency,” said Makary in the agency email reviewed by Focus. “For example, employees can use Elsa to expedite clinical protocol review and reduce the overall time to complete scientific review.”

FDA has set up training sessions for staff to learn how to use Elsa in their daily work. An FDA reviewer who spoke to Focus and was granted anonymity to protect them from potential professional reprisals said they have signed up for the training, but based on initial testing, it seems to be accurately answering their questions.

STAT News first broke the story that FDA was releasing its AI tool ahead of schedule. The publication received a draft version of the planned press release announcing the tool. FDA sources who spoke to STAT raised concerns that its launch was "rushed" and that the agency was "over-inflating its capabilities and failing to set guardrails."

Press release

FDA launches agency-wide AI tool ‘Elsa’ ahead of schedule

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