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CDRH Schedules NGS Workshops

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FDA schedules two November workshops on aspects of next generation sequencing clinical test regulation.

FDA Extends Review of Alexions Kanuma

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FDA extends by three months its review of an Alexon Pharmaceuticals BLA for Kanuma (sebelipase alfa), an investigational enzyme re...

FDA Approves AstraZeneca Expanded Use for Brilinta

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FDA approves an AstraZeneca supplemental NDA for Brilinta (ticagrelor) tablets and a new 60mg dose to be used in patients with a h...

Chugai Gains Breakthrough Status for Hemophilia Therapy

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FDA grants Chugai Pharmaceutical Co. a breakthrough therapy designation for ACE910, an investigational therapy for the prophylacti...

GAO Agrees to Probe FDA Role in Power Morcellator Debacle

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The U.S. Government Accountability Office agrees to investigate FDAs role in first clearing and then warning 20 years later agains...

Animal Drug Regs Updated with Recent Review Actions

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Federal Register final rule: FDA amends the animal drug regulations to reflect application-related actions for new animal drug app...

Genzyme Pays $32 Million to Settle Off-label Case

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Sanofi subsidiary Genzyme agrees to pay $32.5 million to resolve criminal charges that it violated FDA regulations over its allege...

FDA Approves Wellstats Xuriden for Orotic Aciduria

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FDA approves a Wellstat Therapeutics NDA for Xuriden (uridine triacetate), the first approved treatment for patients with heredita...

Private Groups Subject to FDA Regulation: Courts

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Two attorneys write that an 8th Circuit Appeals Court decision should prevent any further attempts to avoid FDA medical device reg...

FDA Wants MUsT in Human OTC Antiseptic Tests

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FDA tells Gojo industries that a MUsT analysis is the best way to evaluate OTC alcohol-based hand antiseptics.