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

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 appointment of a seasoned pharmaceutical executive, George Tidmarsh, to run the FDA’s drug center underscores the ...

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 US Food and Drug Administration will meet its drug approval targets this year despite cutting thousands of staff, the agency’s commissioner said.. The FDA “will have no problem ...

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 ...

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 ...

FDA staffers who spoke with Stat news, meanwhile, called the tool "rushed" and said its capabilities were overinflated by officials, including Makary and those at the Department of Government ...