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Amalgam Risk Study Submitted to FDA is on Journals Most Read List

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A key study on dental amalgam mercury vapor exposure that's been under review at CDRH for a year makes a scientific journals most-...

FDA Will Review Arcalyst sBLA

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FDA says it will review Regenerons sBLA for Arcalyst seeking an indication for preventing gout flares in certain patients.

FDA Denies Public Citizen Avandia Petition

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Public Citizen Health Research Group director Sidney Wolfe blasts FDA for rejecting his groups petition asking that GlaxoSmithKlin...

FDA Approves Regeneron BLA for Eylea

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FDA approves a Regeneron BLA for Eylea (aflibercept injection) for treating neovascular age-related macular degeneration.

Ben Venue Suspends Manufacturing at Troubled Facility

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Boehringer Ingelheims Ben Venue Laboratories suspends manufacturing and distribution of products made at its GMP-troubled Bedford,...

Impax Files ANDA for Generic Fentora

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Impax Laboratories files an ANDA containing a Hatch-Waxman Act Paragraph IV certification for a generic copy of Cephalons Fentora ...

FDA Approves Aptus EndoStapling System

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FDA approves Aptus Endosystems Aptus EndoStapling System, the first system that can repair a failed or problematic aortic endograf...

Dispute Panel to Discuss PMA Denial

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Federal Register Notice: FDAs Medical Devices Dispute Resolution Panel will meet 12/14 to discuss FDAs denial of Ethicon Endo-Surg...

Comments Extended on Countermeasure Devices

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Federal Register Notice: FDA reopens the comment period on an upcoming meeting on advancing regulatory science for highly multiple...

Panel to Discuss Torax Medical PMA for GERD

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Federal Register Notice: FDA's Gastroenterology and Urology Devices Panel will meet 1/11/12 to discuss Torax Medical's PMA for the...