The agency has provided only limited details about its AI pilot as it advances an “aggressive timeline” for the tool's ...

The U.S. FDA announced this week that it deployed a generative AI tool called ELSA, now in use by staff across the agency, ...

For example, Elsa can summarize adverse events, helping FDA reviewers speed up label comparisons and safety profile assessments.

FDA staffers in the Center for Devices and Radiological Health told NBC News that their AI pilot, CDRH-GPT, is buggy, isn't connected to the Internet or the FDA's internal system, and has problems ...

The FDA is using Elsa to accelerate clinical protocol reviews, shorten the time needed for scientific evaluations and identify high-priority inspection targets.

The agency gave a name to the artificial intelligence program it’s been developing to support safety profile assessments, perform faster label comparisons and generate code ...

The agency has provided few details about its AI pilot as it makes moves on its “aggressive timeline” for rollout.