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

Improving how the FDA disseminates already-public information about approved drugs may be unsexy, but it would be a big step ...

With reports that FDA’s AI Elsa is “confidently hallucinating” studies that don’t exist, the use of AI to streamline drug ...

WASHINGTON — Even before he took over the Food and Drug Administration, Marty Makary called for frequent, transparent meetings of the independent panels that advise the agency on ...

The Trump administration‘s “Make America Healthy Again” goals depend on negotiations with food and healthcare industry leaders rather than regulation, the heads of the Food and Drug Administration and ...

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

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

The U.S. Food and Drug Administration on Monday announced the launch of a new generative AI technology that agency leaders said will help its employees do their jobs more efficiently. WHY IT MATTERS ...

The FDA launched a generative artificial intelligence (AI) tool, dubbed Elsa, designed to help employees such as scientific reviewers and investigators work more efficiently, the agency announced ...

Meanwhile, FDA Commissioner Marty Makary highlighted the speed with which the tool was rolled out. "I set an aggressive timeline to scale AI agency-wide by June 30," Makary said.