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...
Media reports say senior Trump administration officials blocked a promising new psychedelic treatment for severe depression from being added to FDAs n...
Amgen rejects an FDA request asking it to voluntarily withdraw its vasculitis drug Tavneos (avacopan) from the U.S. market due to concerns related to ...
FDA grants AstraZeneca and Daiichi Sankyo a priority review for their antibodydrug conjugate Datroway (datopotamab deruxtecan) as a potential first-li...
