FDA commissioner Scott Gottlieb and CDER associate director Leah Christi describe agency efforts to educate prescribers about biosimilars.
FDA warns ELITech Group about QS and MDR violations at its manufacturing facility in The Netherlands.
Federal Register notice: FDA classifies the mass spectrometer system for clinical use for identifying microorganisms into Class II (special controls).
FDA warns Germanys DRG Instruments about QS and MDR violations in its manufacturing of several ELISA devices.
Federal Register notice: FDA classifies as Class 2 devices that detect and measure non-microbial analytes in human clinical specimens to aid in assess...
Federal Register notice: FDA withdraws the marketing of 54 ANDAs requested by Watson Laboratories and Barr Laboratories.
FDA releases its latest batch of Warning Letters that includes DRG Instruments, ELITech Group SAS, Pelvic Therapies, Sohail M. Khan, UVLrx Therapeutic...
FDA commissioner Scott Gottlieb outlines agency steps to promote medical device innovation, including one draft and two finalized guidances.