U.S. senators Joni Ernst (R-IA) and Chuck Grassley (R-IA) write to FDA asking for clarification on its temporary policy for manufacturing alcohol-base...
Federal Register notice: FDA makes available draft recommendations for new permitted daily exposures (PDEs) for the residual solvents 2-methyltetrahyd...
Reuters reports that a shipment of Russian ventilators that have been implicated in fatal hospital fires in that country were admitted into the U.S. a...
FDA clears a 4DMedical 510(k) for its XV Technology, a patented four-dimensional lung imaging process that is intended to rapidly and automatically an...
FDA reminds healthcare facility reprocessing staff to use the correct ASP Sterrad sterilization system decontamination cycle with compatible N95 respi...
FDA approves an Amivas NDA for artesunate for injection 110 mg, powder and solvent for solution, indicated for the initial treatment of severe malaria...
FDA warns Altaire Pharmaceuticals about repeat CGMP violations in its manufacturing of finished drugs.
Federal Register notice: FDA announces a 6/22 virtual public meeting entitled Financial Transparency and Efficiency of the Prescription Drug User Fee ...