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

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.

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

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 ...

FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...

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.

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.

George Tidmarsh, a Stanford University physician who founded Horizon Pharma and later ran La Jolla Pharma, was named head of ...

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

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

Kennedy has since announced that HHS would reverse 20% of the cuts across the agency. Amid news reports describing the layoffs at the FDA, Kennedy did not specify how many people would be reinstated.