With the FDA's new requirements for premarket submission and ongoing monitoring by medical device manufacturers in place, ...
The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed ...
In a conversation with The Regulatory Review, Ropes & Gray partner David Peloquin discusses how clinical research studies are ...
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and ...
The US Food and Drug Administration has finalized new standards that foods must meet before they can be labeled as “healthy.” Requirements now include limits on saturated fat, sodium and added ...
(CNN) — The US Food and Drug Administration has finalized new standards that foods must meet before they can be labeled as “healthy.” Requirements now include limits on saturated fat, sodium and added ...