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FDA Approves Altana Allergy Nasal Spray

[ Price : $8.95]

FDA approves an Altana Pharma NDA for Omnaris (ciclesonide) nasal spray for treating allergic rhinitis nasal symptoms.

Changes Sought in Warning Letter System

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Attorney Larry Pilot, who represented Utah Medical in its successful fight against FDA Warning Letters, says FDA should develop a ...

FDA Asks for New Studies on Antibiotic

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FDA issues a non-approvable letter to Replidyne Inc. on its NDA for antibiotic faropenem medoxomil, and requests additional studie...

Global Harmonization Documents Out

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FDA says Global Harmonization Task Force documents are available.

Despite Outliers Industrys Compliance is Good

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Consulting editor John Scharmann reviews industrys compliance record since 2001 and concludes that high-publicity outliers aside, ...

Roche Recalls CoaguCheck Test Strips

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Roche Diagnostics recalls its CoaguChek PT test strips due to the potential for false elevated test results.

FDA Assigns Class 1 Recall to Medtronic Infusion Pumps

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FDA classifies an earlier reported recall involving Medtronics SynchroMed EL infusion pumps as a Class 1 recall.

Blood Glucose Monitor Guidance Out

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CDRH issues a guidance with recommendations on portable invasive blood glucose monitoring systems.

First-Year Marketing Costs $15 Million

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A new Cutting Edge Information report says drug companies may spend from $1 million to $50 million in first-year promotion of a ne...

Educate Docs, Pharmacists on Unapproved Drugs: Grassley

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Senate Finance Committee chairman Chuck Grassley questions FDA on what it is doing to inform health professionals and patients abo...