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FDA Orders Spinal Dynamic Stabilization System Studies

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FDA says it is requiring 16 manufacturers of Class 2 spinal dynamic stabilization systems to conduct postmarketing safety studies.

Pfizer Defends Misconduct Allegations

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Nearly six weeks after Pfizer agreed to pay $2.3 billion to resolve illegal promotion charges involving several drug products, the...

FDA Panel Backs Glaxo Kidney Cancer Drug

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An FDA advisory panel unanimously votes to recommend approval for GlaxoSmithKlines Votrient (pazopanib) for patients with advanced...

Advisors Narrowly Back New Pegintron Indication

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FDAs Oncologic Drugs Advisory Committee votes 6-4 to recommend approval of Schering-Ploughs Pegintron as adjuvant treatment for pa...

Guidance on H. pylori-Associated Ulcer Treatments

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Federal Register Notice: FDA releases a draft guidance on developing drugs for treating Heliobacter pylori-associated duodenal ulc...

FDAs Culture of Secrecy Will Beat Obama

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FDA Webview editor Jim Dickinson reviews FDAs accelerating record of bureaucratic secrecy against new transparency efforts and con...

FDA Tentative OK for Generic Flomax

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FDA issues a tentative approval for an Impax Laboratories ANDA for a generic version of Boehringer Ingelheim Pharmaceuticals Floma...

sNDA for Avodarts Prostate Cancer Risk Reduction

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GlaxoSmithKline files a supplemental NDA for Avodart (dutasteride) and a claim for prostate cancer risk reduction among men at inc...

Guidance on Developing Drugs for H. pylori-Associated Ulcers

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FDA releases a new draft guidance to assist sponsors in clinical drug development for treating H. pylori-associated duodenal ulcer...

Former FDAer Testifies in Paxil Trial

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A former FDA drug safety official tells a product liability trial jury in Philadelphia that GlaxoSmithKline had complied with all ...