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Guidance on Biological Product Deviation Reporting

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Federal Register Notice: FDA releases a guidance on biological product deviation reporting for licensed manufacturers of biologica...

FDA Panel Recommends Tamoxifen Label Change

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An FDA panel votes to recommend a label revision for breast cancer drug tamoxifen to reflect clinical evidence showing that women ...

FDA Clears InfraReDx Spectroscopic System

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FDA clears a InfraReDx 510(k) application to market a near-infrared spectroscopic system for examining coronary arteries.

Novartis Extends Gleevec Warning to U.S. Labeling

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Novartis extends a Canadian warning on Gleevec and cardiac risk to U.S. labeling.

Ex-counsel Sees Downtrodden Staff, Poverty at FDA

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The monthly meeting of the FDA Alliance gets a vivid picture of FDA poverty and a downtrodden staff from former FDA counsels Stuar...

Discount Store Generic Drugs Will Sell Well

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Consumers tell the Wall Street Journal Online/Harris Interactive Health-Care Poll they are likely to go to mega-stores to buy disc...

FDA/FTC Go After Bogus Diabetes Products

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FDA and FTC launch an enforcement initiative to stop deceptive Internet sales of bogus diabetes products.

Expanded Remicade Indication OK

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FDA approves expanding Remicades indication to include maintaining clinical remission and mucosal healing in patients with moderat...

PDUFA 4 Agreement Open for Public Comment: Jenkins

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CDER Office of New Drugs director John Jenkins tells RAPS that once a negotiated PDUFA 4 reauthorization agreement is reached it w...

FDA OKs MedMiras Rapid HIV Test

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FDA approves MedMiras Reveal G3 Rapid HIV-1 Antibody Test which can deliver results in less than three minutes.