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Guidance on Glaucoma Surgical Devices

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Federal Register Notice: FDA releases a guidance: Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Dev...

Workshop on Warfarin Therapy Monitors

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Federal Register Notice: FDA plans a public workshop 1/25/16 entitled Point of Care Prothrombin Time/International Normalized Rati...

Review Period Set for Trivascular Stent Graft System

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Federal Register Notice: FDA determines the regulatory review period for the Trivascular Ovation Abdominal Stent Graft System for ...

Review Period Set Vizamyl

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Federal Register Notice: FDA determines the regulatory review period for GE Healthcares Vizamyl for the purpose of patent extensio...

FDA OKs StimRelieve Migraine Device Trial

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FDA approves a StimRelieve IDE to launch a clinical trial of what the company describes as the worlds smallest percutaneously impl...

FDA Approves Merckֹs Bridion

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FDA approves a Merck NDA for Bridion (sugammadex) injection for reversing the effects of neuromuscular blockade induced by rocuron...

FDA Clears Viatom Techs Vital Sign Tracker

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FDA clears a Viatom Technologies 510(k) for the Checkme Pro, a connected medical device that tracks a number of vital signs.

New Import System Goes Online in February

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FDA says importers and brokers of agency-regulated products will need to begin using a joint FDA/Customs import system 2/28/2016.

FDA Needs to Publish Promised Biosimilar Guidance: Health Affairs

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A Health Affairs review of how FDA has implemented the biosimilars pathway finds a few issues still needing the agencys attention....

Panel to Discuss Leadless Cardiac Pacemakers

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Federal Register Notice: FDAs Circulatory System Devices Panel will meet 2/18/16 to discuss leadless cardiac pacemaker device tech...