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FDA Clears SonoSite Ultrasound

[ Price : $8.95]

FDA clears a SonoSite 510(k) for the NanoMaxx ultrsound system.

FDA Clears GE Healthcare Carescape Monitor

[ Price : $8.95]

FDA clears GE Healthcares Carescape Monitor B850 to directly link hospital networks, electronic medical records, diagnostic images...

FDA Orders Spinal Dynamic Stabilization System Studies

[ Price : $8.95]

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...

Tobacco Marketing Guidance Out

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Federal Register Notice: FDA releases a draft guidance on tobacco products combined with another regulated product that the agency...

Oncologic Panel Meeting Canceled

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Federal Register Notice: FDAs Oncologic Drugs Advisory Committee scheduled 10/6 has been canceled.

FDA, Oncolytics Reach Agreement on SPA for Reolysin

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FDA reaches an agreement with Oncolytics Biotech Inc. under a Special Protocol Assessment for the design of a Phase 3 trial of Reo...

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FDA releases a new draft guidance to assist sponsors in clinical drug development for treating H. pylori-associated duodenal ulcer...