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Consumer Information on: Innova Vascular Self-Expanding Stent System
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Webcast Archive and Presentation Slides added to Public Workshop – Next Generation Sequencing
The Food and Drug Administration (FDA) announced the following public workshop entitled “Next Generation Sequencing-Based Oncology Panels.” The purpose of this workshop was to obtain feedback on analytical and clinical validation approaches for next generation sequencing (NGS)-based oncology panels. Comments and suggestions generated through this workshop will help guide the development of appropriate regulatory standards…
February 18, 2016 MDUFA III Performance Report
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Hydrogen Peroxide Contact Lens Solution
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Zika Virus Emergency Use Authorization – Zika MAC
On February 26, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention’s (CDC) Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) for the presumptive detection of Zika virus-specific IgM in human sera or cerebrospinal fluid (CSF) that is submitted alongside…
FDA-Industry MDUFA IV Reauthorization Meeting, January 20, 2016
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FDA-Industry MDUFA IV Reauthorization Meeting, January 27, 2016
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Neurosurgical Head Holders (Skull Clamps) and Device Slippage: FDA Safety Communication
Date Issued: February 25, 2016 Audiences: Health care providers who use neurosurgical head holders, including: Ear, Nose and Throat Specialists, Neurological Surgeons, Orthopaedic Surgeons and Operating Room Staff Hospital staff responsible for maintenance of medical devices Medical Specialties: Neurosurgery, Otolaryngology, Orthopaedics Device: A neurosurgical head holder (skull clamp) system is a device used to secure…
Class I Medical Device Recall: Cook Medical Expands Recall for Beacon Tip Angiographic Catheters to Include Additional Product Lots
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