FDA updates the safety labeling for the widely used chemotherapy drugs capecitabine (Genentechs Xeloda) and fluorouracil (multiple manufacturers) to s...
FDA publishes a guidance with recommendations on computer software assurance for computers and automated data processing systems used as part of medic...
President Trump signs a government spending bill that officially reinstates FDAs Rare Pediatric Disease Priority Review Voucher program.
FDA warns Austin, TX-based Flextronics America about Quality Systems violations in its manufacturing of a continuous glucose meter.
FDA warns Indias Cohance Lifesciences about CGMP violations in its production of drugs at one of its manufacturing sites.
Three drug trade associations give FDA their perspectives on increasing access to nonprescription drugs.
Three Hogan Lovells attorneys analyze the new FDA medical device inspection compliance program and caution manufacturers to begin working on the signi...
FDA classifies Abbott Diabetes Cares recall of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring sensors as a Class I...
