FDA publishes a draft guidance explaining how it periodically assesses drugs that have been granted breakthrough therapy designation and rescinds thos...
University of Illinois psychiatry professor Anand Kumar calls on FDA to closely reevaluate the accelerated approval program to be sure it only uses bi...
Medtronic recalls (Class 1) one lot of batteries for its HeartWare Ventricular Assist Device due to welding defects that allow separation of the two c...
The House Appropriations Committee votes 31 to 26 to approve an FDA spending bill for fiscal year 2023 that will boost the agencys discretionary fundi...
FDA publishes a draft revising a 2013 guidance on a CGMP framework for preventing cross-contamination in non-penicillin beta-lactam drugs.
FDA says the Baxter Healthcare recall of its Volara system due to risk of respiratory distress in home use is Class 1.
The Vermont federal court approves a consent decree of permanent injunction against Colchester, VT-based Edge Pharm, a compound pharmacy accused of ma...
FDA clears the Medtronic LigaPASS ligament augmentation system.