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Quality System Violations Found at Abbott Molecular

[ Price : $8.95]

FDAs Chicago District Office warns Abbott Molecular on Quality System violations at its Des Plaines, IL, manufacturing facility.

FDA OKs Chili Pepper Pain Patch

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FDA approves a NeurogesX, Inc. NDA Qutenza (capsaicin) 8% patch for managing neuropathic pain due to postherpetic neuralgia.

FDA Warns of Plavix-Prilosec Interaction

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FDA cautions that taking Prilosec with Plavix reduces Plavix anti-clotting ability by up to 45%.

FDA Adds Health Info to Everyday Health

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FDA says it is collaborating with Everyday Health on a co-branded Web site and weekly newsletter.

Dorgan Readying Drug Import Bill

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Sen. Dorgan says he will try to amend the Senate healthcare reform bill to include a provision allowing some drug imports.

Panel to Discuss Bladder Cancer Diagnostic

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Federal Register Notice: FDAs Oncologic Drugs Advisory Committee will meet 12/17 to discuss Photocures Hexvix Kit to aid in diagno...

Novartis Positive Data on Adjuvanted H1N1 Vaccine

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Novartis says interim clinical data show that its MF59-adjuvanted vaccine was well tolerated and could potentially quadruple the N...

Advisors Asked About Spiriva Efficacy, Safety Data

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FDA asks the Pulmonary-Allergy Drugs Advisory Committee whether clinical trial data support a claim that Pfizer/Boehringer Ingelhe...

FDA Rejects NDA for Neuromed Pain Drug

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FDA tells Neuromed that it cannot approve its pending NDA for Exalgo (hydromorphone HCl) extended release tablets, indicated for m...

Researchers Mull Niacin/Ezetimibe Trial Data

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Researchers from Johns Hopkins say that just-released clinical trial data showing that cholesterol-lowering niacin was superior to...