FDA launches Elsa, an AI tool designed to accelerate agencywide operations

The U.S. Food and Drug Administration (FDA) has launched Elsa, an AI tool designed to modernize and speed up agency-wide operations ranging from scientific reviews to investigations.

Marty Makary, the head of the agency, announced the launch on Monday, noting that the project was completed ahead of schedule. In May, he set a deadline to implement AI across all FDA centers by June 30, following the successful completion of a pilot project.

A day earlier, Wired had reported that the FDA held discussions with Microsoft (NASDAQ:MSFT)-backed AI startup OpenAI as part of a potentially broader effort to leverage AI at the agency to accelerate drug evaluations and approvals.

“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.

As a large language model–powered AI tool, Elsa can assist the agency’s employees with reading, writing, and summarizing. For example, Elsa can summarize adverse events, helping FDA reviewers speed up label comparisons and safety profile assessments.