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FDA releases a guidance on Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization that addresse...[ Price : $8.95]
FDA clears a Corindus Vascular Robotics 510(k) for the CorPath GRX, the second generation of its CorPath Vascular Robotic System.[ Price : $8.95]
Federal Register Notice: FDA announces the issuance of Emergency Use Authorizations for four in vitro diagnostic devices for detec...[ Price : $8.95]
FDA sends Regeneron Pharmaceuticals and Sanofi a Complete Response Letter on their BLA for sarilumab, an investigational interleuk...[ Price : $8.95]
HeartWare Inc. begins a Class 1 recall of its Ventricular Assist Device controller due to a loose power connector which may cause ...[ Price : $8.95]
A summary of draft legislation shows funding changes under the MDUFA 4 agreement.[ Price : $8.95]
Two stakeholders suggest ways to improve an FDA draft guidance on using real-world evidence in medical device regulatory decision-...[ Price : $8.95]
FDA places a partial clinical hold on AstraZenecas enrollment of new patients with head and neck squamous cell carcinoma in clinic...