The former officials said the FDA's plans to revamp how certain life-saving vaccines are handled would "disadvantage the ...

A dozen prior leaders of the U.S. Food and Drug Administration issued a scathing denunciation of an FDA memo to staff that ...

Twelve former commissioners, in a New England Journal of Medicine article, said they were “deeply concerned” by a leaked memo from the agency’s vaccine regulator.

The US Food and Drug Administration’s new vaccine approval philosophy upends established regulatory practices and could put the health and safety of Americans at risk, according to an article written ...

A dozen former leaders of the U.S. Food and Drug Administration (FDA) on Wednesday slammed the Trump administration over its ...

Twelve former U.S. FDA commissioners said on Wednesday they were deeply concerned about proposed changes to vaccine ...

Vinay Simlot joined the Washington bureau in June 2024. Previously, he worked at WBIR-TV in Knoxville, Tennessee. Vinay is a graduate of the University of Colorado-Boulder with degrees in Aerospace ...

A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, ...

In an article that reads like informal guidance, U.S. FDA Commissioner Marty Makary and CBER Director Vinay Prasad discussed the criteria for using the agency’s novel plausible mechanism pathway for ...

The FDA has introduced a new “plausible mechanism pathway” aimed at expediting approval of personalized therapies for rare diseases. The approach, detailed in a Nov. 12 article in The New England ...