FDA employees report the agency's new AI assistant produces incorrect answers and lacks essential safeguards. (Shutterstock) ...

The U.S. Food and Drug Administration (“FDA”) has fast-tracked the rollout of its AI tool, Elsa, originally planned for June 30, with Commissioner Dr ...

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 place, it’s bees and wasps. Every week brings a fresh round of horrors that ...

This week on "The Readout LOUD" podcast: an AI experiment at the FDA and how Novo Nordisk is trailing in the obesity drug ...

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

An agile, transparent, and ethics-driven oversight system is needed for the U.S. Food and Drug Administration (FDA) 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 ...

A new FDA artificial intelligence tool designed to streamline medical device reviews is faltering in its early rollout stages, raising concerns for agency staff and ethics experts about its ...