FDA acting commissioner Janet Woodcock announces that CDER deputy director for operations Patrizia Cavazzoni has been appointed CDER director.
FDA classifies as Class 1 a Medtronic recall of all unused Valiant Navion thoracic stent grafts due to stent fractures and endoleak concerns.
Smisson-Cartledge Biomedical recalls (Class 1) its ThermaCor 1200 Rapid Thermal Infusion System Disposable Sets because a cassette that warms fluids d...
FDA grants Cosmo Artificial Intelligence a de novo marketing authorization for the GI Genius, the first device that uses artificial intelligence to as...
Federal Register notice: FDA withdraws approval of five ANDAs from multiple holders because they have repeatedly failed to file required annual report...
Federal Register notice: FDA announces a 5/20 public meeting entitled Animal Drug User Fee Act.
Federal Register notice: FDA announces a 5/20 public meeting entitled Animal Generic Drug User Fee Act.
FDA tells Provention Bio that it has identified deficiencies with its BLA for diabetes therapy teplizumab that preclude labeling and post-marketing re...