The FDA is looking into how AI could help with final drug approvals and improve internal tasks like checking whether an ...

A former critic of FDA and Pharma will now oversee the regulation of costly and complicated biologics like vaccines, gene therapies, and blood supply.

For both foods and drugs, most foreign inspections were pre-announced; the agency also re-emphasized its ban on inspectors ...

FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease ...

Vinay Prasad, a critic of the Food and Drug Administration, has been tapped as the agency’s top regulator of vaccines, gene ...

The FDA doesn’t plan to execute a reorganization of the agency but will consolidate offices that handle travel, technology, ...

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the ...

Following massive layoffs and cuts at the FDA, Makary’s plan for the agency is yet to fully unfold. But he has hinted at what ...

Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by ...

Serious consideration must be given by FDA as to whether the agency has the authority to dispatch the self-affirmed Generally ...