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FDA Raises Many Ampligen Concerns

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FDA tells the Arthritis Advisory Committee it has concerns about the efficacy and safety of Hemispherx Biopharmas Ampligen in trea...

Merck, GE to Collaborate on Alzheimers Candidate

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Merck and GE Healthcare collaborate on a clinical study and license and supply agreement to use GEs investigational PET imaging ag...

Comments Sought on Device Review Assessment

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Federal Register Notice: FDA seeks comments on the comprehensive assessment of the device submission review process.

FDA Clears Ascendx Vertebral Fracture System

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FDA clears an Ascendx Spine 510(k) for its Ascendx VCF Repair System, intended for use in treating vertebral compression fractures...

Axelrad to be Woodcock Senior Advisor

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CDER Office of Regulatory Policy director Jane Axelrad is becoming Janet Woodcocks senior advisor to take the FDA lead on drug com...

Boxed Warning Added to Incivek Label

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Vertex says a Boxed Warning has been added to the Incivek label to highlight the risk of fatal and non-fatal serious skin reaction...

Safety Board Backs Rockwell Iron Replacement Therapy

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Rockwell Medical says it has received backing from an independent Data Safety Monitoring Board providing oversight for the company...

NEWSROOM CLOSED FOR THE HOLIDAYS

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FDA Webview has closed its newsroom for the traditional Festive Season holiday break. We will resume normal operations on January ...

FDA Approves Angiotech Biopsy-sealing System

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FDA grants de novo approval for Angiotechs Bio-Seal Lung Biopsy Tract Plug System, a device that seals punctures left by lung biop...

FDA Sends Info on Emergency Use Authorization to OMB

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Federal Register Notice: FDA submits to the Office of Management and Budget a proposed collection of information on reporting and ...