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Mentor Says FDA Satisfied with Answers

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Mentor and FDA say the agency was satisfied with answers it obtained from Mentor when looking into a whistleblowers allegations ab...

FDA Posts New Transparent Safety Board Summary

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Responding to criticism that CDERs Drug Safety Oversight Board does not reflect much-touted transparency, the agency posts an enha...

FDA Preemption in Drug Labeling Rejected by Judge

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A New Jersey federal judge rejects an FDA effort last January to protect drug companies from state failure to warn cases by assert...

Former Olympic Star Touts Biomet Hip

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U.S. Olympics gymnast Mary Lou Retton says she has had a total hip replacement using the Biomet M2a-Magnum system.

Bayer Suspends 2 Over Trasylol; Outside Probe Begins

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Announcing an outside investigation, Bayer says it has suspended two employees who played pivotal roles in the companys delayed su...

FDA OKs Expanded Aricept Use

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FDA approves an expanded use for Eisai Inc.s Aricept treating severe dementia in patients with Alzheimer's disease.

Antipsychotic Use Not So Good for Alzheimers Patients

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A new study finds little benefit for Alzheimers patients in commonly used off-label atypical antipsychotic drugs.

How to Measure Industry Compliance and FDA Needs?

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Consulting editor John Scharmann asks whether FDA enforcement of GMPs should give way to a new and more measurable quality complia...

FDA Tentatively OKs Tevas Generic Risperdal

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FDA tentatively approves a Teva Pharmaceutical Industries ANDA for a generic version of Janssen's Risperdal.

FDA Approves Avastin Combo Treatment in Lung Cancer

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FDA approves Genentechs cancer drug Avastin for combination use with carboplatin and paclitaxel in non-small cell lung cancer pati...