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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...

80% of Docs Want DTC Ban for New Drugs

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Four-fifths of doctors surveyed by MedPanel say they favor an enforced moratorium on DTC ads for newly-approved drugs.

Orapred Web Site Doesnt Have Risk Info

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A DDMAC Warning Letter says a BioMarin Web site for Orapred minimizes risk, broadens the indication, and makes unsubstantiated com...

Solvay/Wyeth NDA for Schizophrenia Drug

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Solvay Pharmaceuticals and Wyeth Pharmaceuticals submit an NDA for bifeprunox, an atypical antipsychotic indicated for treating sc...

McNabb, Parents in Novartis Diabetes Effort

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Novartis enlists the help of Eagles quarterback Donovan McNabb and his parents in a diabetes education effort.

Guidance on Investigating OOS Results

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Federal Register Notice: FDA releases a guidance on investigating out-of-specification test results for pharmaceutical production.