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FDA clears a 3D Systems 510(k) for its 3D-printed, patient-specific cranial implant VSP PEEK Cranial Implant and its use in restor...[ Price : $8.95]
FDA issues Zydus Lifesciences a four-item Form FDA-483 after inspecting the firms manufacturing facility (Matoda, Gujarat, India)....[ Price : $8.95]
FDA grants Soligenix an orphan drug designation for the active ingredient in MarVax vaccine against MARV infection.[ Price : $8.95]
Abbotts Thoratec unit recalls its HeartMate II and HeartMate 3 Left Ventricular Assist System due to an issue called extrinsic out...[ Price : $8.95]
CDER announces the launch of its Center for Clinical Trial Innovation, which will focus on promoting clinical trial innovation act...[ Price : $8.95]
Fresenius Kabi USA recalls (Class 1) its large-volume pump software of the Ivenix Infusion System due to software anomalies that h...[ Price : $8.95]
FDA classifies a December inspection at Sun Pharmaceutical Industries Dadra, India facility as official action indicated.[ Price : $8.95]
FDAs Oncologic Drugs Advisory Committee unanimously votes (12 to 0) that the totality of data are adequate to support the use of m...