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Penn States Message to FDA

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FDA Webview editor Jim Dickinson sees a disturbing parallel between the Penn State sex scandal and FDAs equally toxic culture of l...

FDA Accepts Genentech NDA for Skin Cancer Drug

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FDA accepts for review a Genentech NDA for vismodegib, indicated for treating adults with advanced basal cell carcinoma.

Trilipix May Not Lower Heart Attack, Stroke Risk: FDA

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FDA says that ACCORD trial results show that Abbotts Trilipex may not lower a patients risk of heart attack or stroke.

Mizuho Table Recall is Class 1

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FDA says that Mizuhos recall of its OSI modular table systems due to the potential for patient injuries is a Class 1 recall.

Woodcock on Building Quality In

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CDER director Janet Woodcock discusses her concept of building quality in cooperatively to the structure of drug clinical trials....

CBO Sees Generic Drug Legislation Savings

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The Congressional Budget Office estimates a reduction in federal budget deficits of nearly $5 billion over 10 years from a bill to...

FDA Accepts QRxPharma NDA for Pain Drug

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FDA accepts for review a QRxPharma Limited 505(b)(2) NDA for MoxDuo (morphine and oxycodone) IR, indicated for treating moderate t...

Drop Waxman-Hatch Generics Incentive: Researchers

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The Generic Pharmaceutical Association blasts research funded by Pharmaceutical Research and Manufacturers of America calling on C...

FDA Grants Fast Track for MS Therapy

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FDA grants Opexa Therapeutics fast track status for tovaxin and its use in treating patients with secondary progressive multiple s...

Rothenberg Permanently Debarred

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Federal Register Notice: FDA issues an order permanently debarring Gayle Rothenberg from providing services to anyone with an appr...