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

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

U.S. pharmaceutical companies are increasingly licensing new drugs from China. Former FDA Commissioner Scott Gottlieb ...

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 ...

Recent FDA alert reveals concerning side effects of topical finasteride hair treatments that may persist long after stopping ...

President Trump issued an Executive Order (EO) titled “Regulatory Relief to Promote Domestic Production of Critical Medicines ...

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

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