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Ben Venue Suspends Manufacturing at Troubled Facility

[ Price : $8.95]

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

Impax Files ANDA for Generic Fentora

[ Price : $8.95]

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...

OMB OKs Info on Dietary Ingredient Premarket Notification

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Federal Register Notice: The Office of Management and Budget approves a collection of information on premarket notification for a ...

Guidance on Medication Guides and REMS

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Federal Register Notice: FDA releases a guidance, Medication Guides Distribution Requirements and Inclusion in Risk Evaluation an...

FDA Warns Two Firms on Unapproved Eye Drug

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FDA sends Warning Letters to two manufacturers and distributors of unapproved fluorescein injection, a dye injected into the vein ...

NDA for Leukemia-treating Erwinaze Approved

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FDA approves an EUSA Pharma NDA for Erwinaze (asparaginase Erwinia chrysanthemi) to treat certain patients with acute lymphoblasti...