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FDA Accepts NicOx NDA for Filing

[ Price : $8.95]

FDA accepts for filing NicOxs NDA for naproxcinod to treat osteoarthritis signs and symptoms.

W.H.O. Dental Panel Backs Away from Mercury Amalgam

[ Price : $8.95]

Implicitly contradicting an FDA regulatory finding that mercury-based dental amalgam is safe, a W.H.O.-convened international expe...

Temple to Focus on Clinical Science in CDER Reorganization

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CDER Office of Medical Policy director Robert Temple moves up in CDER to Center deputy director for clinical science and away from...

Comments Sought on Biologic, Tissue Product Deviations

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Federal Register Notice: FDA seeks comments on information collection requirements on biological product deviations and human cell...

Quality System Violations Found at Abbott Molecular

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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...