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FTC Wont Challenge Audit Programs

[ Price : $8.95]

The Federal Trade Commission says it appears that two Rx-360 supplier audit programs have a useful purpose and will not harm compe...

Companies Should Cooperate with Research: Journal

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A New England Journal of Medicine editorial faults GlaxoSmithKline for refusing to provide drugs and placebos for government-spons...

Companies Recall Supplements with Aromatase Inhibitors

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FDA says five companies are recalling products containing aromatase inhibitors they marketed as dietary supplements.

Risk Communication Panel to Meet

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Federal Register Notice: FDAs Risk Communication Advisory Committee will meet 11/8-9 to discuss ongoing communications programs an...

FDA Panel Back Blood Thinner

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FDA's Cardiovascular and Renal Drugs Advisory Committee votes unanimously to recommend approval of Boehringer Ingelheim's blood th...

Franken Presses Hamburg on 510(k) Changes

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Sen. Al Franken calls on FDA to take seriously concerns expressed by Minnesota medical device companies over plans to reform the 5...

FDA Clears Normative Database for Optovue

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FDA clears an Optovue 510(k) for its Normative Database for the RTVue OCT device used as a reference tool in assessing retina nerv...

Oncologists Debate Wisdom of Melanoma Trial Protocol

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A New York Times article describes the debate over whether new genetically engineered cancer treatments are best evaluated through...

Hill Asks J&J Execs to Testify on Childrens Drug Recalls

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The House Oversight and Government Reform Committee asks two Johnson & Johnson executives to clarify information on the companys r...

FDA Needs a Global Regulatory Alliance

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CDER compliance director Deborah Autor says a worldwide alliance of drug regulators is needed because no country can keep up with ...