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FDA clears a Life Spine 510(k) for the Long Bow Expandable Lateral Interbody System.[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Brava and West Coast Laboratories.[ Price : $8.95]
FDA grants MedImmune a fast track designation for its investigational monoclonal antibody MEDI3902 for preventing nosocomial pneum...[ Price : $8.95]
FDA says it will require a clinical endpoint study including an analysis of adverse events for ANDAs citing Warner Chilcotts Estra...[ Price : $8.95]
FDA issues a guidance on its implementation of the revised custom device exemption from the FDA Safety and Innovation Act.[ Price : $8.95]
Amgen files a BLA for blinatumomab, seeking approval for the investigational bispecific T cell engager (BiTE) antibody construct f...[ Price : $8.95]
FDA approves a W. L. Gore & Associates PMA for its Viabahn Endoprosthesis for interventional treatment of in-stent restenosis in t...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on generic clearance for the collection of qualitative f...