FDA publishes a guidance explaining the process for requesting a waiver, exception, or exemption from provisions of the Drug Supply Chain Security Act...
Washington Legal Foundation says the 2nd Circuit Court of Appeals upheld the dismissal of a case against Forest Pharmaceuticals over its Lexapro, agre...
An FDA online paper describes CDER research into and clinical applications of bispecific antibodies.
Regeneron says it will respond to a recent FDA complete response letter on the companys BLA for a higher dose of Eylea (aflibercept) 8 mg to treat pat...
FDA warns Erlanger, KY-based RenatiLabs that it is illegally marketing human cell products that are manufactured with significant CGMP deviations.
Federal Register notice: FDA announces the publication of modifications the agency is making to its list of standards recognized for use in premarket ...
Federal Register notice: FDA seeks comments on an information collection revision entitled Premarket Notification for a New Dietary Ingredient21 CFR 1...
FDA warns Centaur Pharmaceuticals about CGMP issues in its manufacturing of drugs at its facility in Maharashtra, India.
