President Biden is yet again facing backlash over the FDA’s booster approval process, which recommended boosters for children this week without convening a panel of advisors to weigh in on the matter.

Learn how an Abbreviated New Drug Application (ANDA) helps generic drugs get FDA approval without clinical trials, ensuring safety and bioequivalence with brand-name drugs.

Alden Abbott served as Deputy Director of Edwin Meese III Center for Legal and Judicial Studies at The Heritage Foundation. Anticompetitive manipulation of the regulatory process is a serious problem.

FDA's challenges — such as insufficient staffing — can create inefficiencies in the process and potentially put lives at risk ...

According to the Food and Drug Administration (FDA), the traditional paradigm of medical device regulation was not designed for adaptive artificial intelligence and machine learning technologies. As a ...

President Donald Trump on Labor Day asserted that a coronavirus vaccine could be ready "during the month of October" — just weeks before the November 3 presidential election. Given that it typically ...

Washington State University fired up the grill for “CRISPR sausages” made with pork from gene-edited pigs. WSU is the first university to make meat from gene-edited livestock available for human ...

WASHINGTON — An article that appeared Sept. 12 in The New England Journal of Medicine urged the US Food and Drug Administration to take a more active role in food safety, specifically in the Generally ...

As the US Food and Drug Administration publicizes its plans to overhaul the process for manufacturers that want to market medical devices in the United States, a year-long investigation by a nonprofit ...