With a Trump-driven reduction of nearly 2,000 employees, agency officials view artificial intelligence as a way to speed ...

In JAMA, the FDA's Makary and Prasad said they will focus on modernizing review processes and lowering drug costs but don't outright mention precision medicine.

The FDA announced last week it launched Elsa, an AI tool designed to help employees work better. AI also is impacting ...

In an interesting and somewhat unexpected turnabout over the last six months, FDA has pivoted its focus from regulating ...

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

There are problems with generative AI, and there need to be guardrails and there needs to be human oversight," said Jason ...

Writing for SBM these days is a bit like being in one of those cash grab machines, though instead of money flying over the ...

The Food and Drug Administration has officially launched "Elsa," a generative artificial intelligence platform designed to ...

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

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

FDA staffers in the Center for Devices and Radiological Health told NBC News that their AI pilot, CDRH-GPT, is buggy, isn't ...