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FDA grants a fourth breakthrough device designation for SeaStar Medicals Selective Cytopheretic Device.[ Price : $8.95]
FDA releases the form FDA-483 with nine observations from an inspection at the Staska Pharmaceuticals outsourcing facility in Benn...[ Price : $8.95]
Three mental health stakeholders call on two FDA advisory committees to recommend changes to the clozapine REMS.[ Price : $8.95]
FDA clears a Zeta Surgical 510(k) for its Zeta Navigation System for use with expanded instruments and enhanced hospital connectiv...[ Price : $8.95]
FDA raises questions to be considered by members of its General and Plastic Surgery Advisory Committee about IceCare Medicals ProS...[ Price : $8.95]
FDA extends by three months its review of an Organon supplemental NDA for Vtama (tapinarof) cream and its use for treating atopic ...[ Price : $8.95]
FDA warns the Kittanning, PA-based Armstrong County Memorial Hospital IRB about objectionable conditions identified in a Bioresear...[ Price : $8.95]
FDA commissioner Robert Califf says collaboration with external stakeholders is needed to adequately monitor and regulate artifici...