US Food and Drug Administration Commissioner Marty Makary named agency veterans to lead tobacco regulation and inspections, two high-profile areas, according to documents seen by Bloomberg.

The Food and Drug Administration is shifting its annual COVID-19 vaccine approval policies to focus on Americans older than age 65 and other "high-risk" individuals, while increasing the standard ...

Top FDA leaders estimate more than 100 million Americans would be eligible for the shots under the new framework. In past years, the shots have been broadly recommended, including to children and ...

The vaccine's prospects were thrown into doubt after the FDA missed its April 1 target to approve the shot, which is a more traditional protein-based vaccine unlike its messenger RNA-based rivals.

A Form 483 is issued at the conclusion of an FDA inspection when investigators observe any conditions that may violate the Food, Drug, and Cosmetic (FD&C) Act. Such observations can lead to a ...

In 2024, the FDA conducted an inspection of operations at the Pace® Life Sciences laboratories located in Oakdale, MN, and San Germán, Puerto Rico, with favorable outcomes from the harmonized ...

This approval marks the 46th successful regulatory inspection for QPS India over the past two decades, including previous audits by the US FDA, EMA, UK MHRA, WHO, ANVISA, NPRA, NABL, GCC ...

The CVR lost around three quarters of its value after BMS revealed on its third-quarter results call that the FDA still hasn’t carried out an inspection of a manufacturing facility that will be ...