FDA approves an AstraZeneca NDA for Airsupra (albuterol/budesonide) for the as-needed treatment or prevention of bronchoconstriction and to reduce the...
Federal Register notice: FDA issues an emergency use authorization for a Life Technologies in vitro diagnostic device for detecting and diagnosing mon...
Some FDA and CDC vaccine advisors say they should have been given Moderna Covid booster infection data, even though it was early and had limitations, ...
FDA Webview editor Jim Dickinson supports a Washington Post editorial board recommendation made after a meeting with the agencys leadership that food ...
An FDA Office of Criminal Investigations probe leads to guilty pleas by Jennifer Robertson (Battle Creek, MI) and Michelle McAllister (Jerome, MI) ove...
Academic medical center researchers say a loophole in the law allows FDA to clear 510(k) submissions whose predicate was subject to a Class 1 recall.
SheppardMullin attorneys review FDA 2022 actions in several regulatory areas and look ahead to 2023.
FDA warns Sun Pharmaceuticals about CGMP violations and other issues in its production of finished drugs in Gujarat, India.
