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 ...

Dr. George Tidmarsh, a Stanford pediatrics adjunct professor and former pharmaceutical executive, is FDA Commissioner Marty ...

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

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.

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.

The president's proposed budget cuts to the NIH would eventually result in fewer drugs on the market, the U.S. Congressional ...

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

In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug ...