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The American Clinical Laboratory Association submits comments to an FDA draft guidance on medical device predetermined change cont...[ Price : $8.95]
In an interview the day after the election, president-elect Donald Trumps top health advisor Robert F. Kennedy Jr. says there are ...[ Price : $8.95]
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 ...