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Comments Extended on Generic Drug User Fee Meeting

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Federal Register Notice: FDA reopens the comment period on a 9/17 generic drug user fee public meeting.

Guidance on Cellular Therapy for Cardiac Disease

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Federal Register Notice: FDA releases a guidance on cellular therapy for cardiac disease.

Digital Mammography Devices Reclassified into Class 2

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FDA reclassifies full field digital mammography systems into Class 2.

Hospira Providing Loaner Symbiq Pumps in Class 1 Recall

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Hospira says it is providing loaner pumps for critical care areas while it upgrades recalled Symbiq pumping mechanisms.

How FDAs World Could be Impacted by a Republican-run House

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FDA Webview examines the outlook for FDA and its regulated industries after Republicans take over the House of Representatives.

FDA Clears Covidien Device for DVT

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FDA clears a Covidien 510(k) for the Kendall SCD Compression Comfort Sleeve and Kendall SCD 700 Series Controller to reduce the ri...

FDA Extends Ipilimumab BLA Review Time

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FDA extends its decision date for Bristol-Myers Squibbs ipilimumab BLA by 90 days.

Appeals Court Affirms Injunction Against Apotex Generic Drug

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An appeals court affirms a lower court's preliminary injunction that blocks Apotex from marketing a generic version of AstraZeneca...

Supreme Court Need Not Hear Generic Preemption Case: Feds

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The U.S. Solicitor General tells the Supreme Court there is no need for it to agree to hear appeals by two drugs companies from an...

Questions Raised About CDRH Role in VNS Approval

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A British Medical Journal report blasts CDRH for not investigating 900 deaths in patients using Cyberonics vagus nerve stimulator....