The federal agency introduced Elsa last month, boasting about the AI tool's ability to increase efficiency at the FDA.

The U.S. Department of Health and Human Services is moving ahead with a plan to cut 10,000 jobs after the Supreme Court ...

But three of those FDA employees told CNN that Elsa just makes up nonexistent studies, something commonly referred to in AI ...

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is getting better, and use is not mandatory.

FDA officials say the assistant is flawed, just as the Trump administration stresses AI adoption in healthcare.

Loss of support staff has slowed critical investigations of drug manufacturers. Little relief has materialized.

With reports that FDA’s AI Elsa is “confidently hallucinating” studies that don’t exist, the use of AI to streamline drug review and speed up approval is not here yet.

The investigative unit, which looks into potential safety issues with drugs, vaccines, medical devices, and other products, has had a retention problem for years. Inspectors leave so often that, even ...

Despite ambitions to streamline regulatory review, FDA’s Elsa platform has been prone to hallucinations, prompting internal scrutiny and questions about AI reliability and governance.

Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...

In the first six months of 2025, 385 employees resigned from the Center for Drug Evaluation and Research, compared with under 130 staff during the same period last year.

Two months after laying off 20% of its staff, Korro Bio says it has not retreated from its “3-2-1” corporate strategy as it prepares to release interim clinical data on its lead candidate KRRO-110 in ...