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.

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 ...

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.

The FDA appointed George Tidmarsh, MD, PhD, to be the nation's top drug official in July. The Center for Drug Evaluation and ...

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.

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 ...

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 — 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 ...

The answer may surprise you. The Food and Drug Administration (FDA) plays a key role in the development of new biopharmaceutical products. In particular, the FDA provides an essential public service ...