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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...

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.

Merck Slapped with 2 'Complete Response' Letters

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Merck receives two complete response letters for two NDAs under FDA review one on an oral contraceptive and the other on a glauco...

FDA Wont Ban Antibiotic Use in Food Animals

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FDA denies two citizen petitions asking it to ban all non-therapeutic uses of antibiotics in feed animal food and water.

Contaminated Pet Food from an Industry Too Big to Fail?

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Consulting editor John Scharmann traces the contamination of dry pet food with salmonella back to animal rendering plants, an indu...

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.