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

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

Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...

For years, inspectors have uncovered dirty equipment, contaminated supplies and fraudulent testing records in some overseas factories — serious safety and quality breaches that can sicken or kill ...

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

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

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

But just hours after employees were shown the door, Barclay Butler, the agency’s new chief operating officer, asked top FDA officials to identify employees to keep working for the next two ...

FILE - The U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md, Thursday, Aug. 2, 2018. (AP Photo/Jacquelyn Martin, File ...

FDA commissioners aren’t typically involved in the agency’s day-to-day medical reviews, but they often serve as a buffer between FDA scientists and political forces elsewhere in government.

WASHINGTON (AP) — Weeks after ordering all Food and Drug Administration employees back into the office, the agency is reversing course, allowing some of its most prized staffers to work remotely ...