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HEAT Fighting Healthcare Fraud

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Assistant attorney general Tony West says the federal governments comprehensive enforcement action in healthcare fraud has netted ...

Do REMS Have Research Materials Applicability?

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A citizen petition asks FDA for guidance on the degree to which sellers of research materials for non-clinical that are the same a...

CBER Co-sponsors HCMV Vaccine Workshop

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Federal Register Notice: CBER will co-sponsor a public workshop on developing and evaluating human cytomegalovirus vaccines.

FDA Clears Fresenius Hemodialysis System Enhancements

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FDA clears a Fresenius Medical Care 510(k) for enhanced features including the Clinical Data Exchange for its 2008T hemodialysis d...

CDER Outlines Dispute Resolution Process

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CDER has outlines the paths for stakeholders to take to resolve disputes with Center staff.

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....