Marty Makary says the FDA will plow ahead with big plans on ultra processed foods, dietary guidelines, and expedited drug and ...

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

The FDA is still on track to meet its user fee targets despite a higher-than-normal vacancy rate among scientific reviewers.

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

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

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

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

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 ...

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

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

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.

Drugmaker Sarepta Therapeutics says it won't comply with a request from U.S. regulators to halt all shipments of its gene ...