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Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites 14 tobacco product manufacturers, Gibson Laboratories and Platinum Strategies.

Dietary Supplement Ad Review Extended

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The Council for Responsible Nutrition and the National Advertising Review Council are extending for another five years their progr...

PhRMA Wants FDA Logo on Online Sites with Good Info

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PhRMA says FDA should put an easily recognized seal of approval on legitimate, FDA-regulated online health information

FDA OKs Wright Medicals Hip Resurfacing System

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FDA approves a Wright Medical Group PMA for the Conserve Plus Total Hip Resurfacing System.

FDA Clears Vascular Solutions Catheter

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FDA clears a Vascular Solutions 510(k) for the GuideLiner catheter.

FDA Review Extension on Glaxo/XenoPort NDA

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FDA extends by three months its review of a GlaxoSmithKline and XenoPort NDA for GSK1838262/XP13512 (gabapentin enacarbil), indica...

Promoting Off-label Uses is Big Business: Bloomberg

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A detailed Bloomberg news report says that many drug companies repeatedly participate in illegal off-label promotion of unapproved...

Guidance on Reducing West Nile Virus Transmissions

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Federal Register Notice: FDA releases a guidance on the use of nucleic acid tests to reduce the risk of transmission of West Vile ...

Pointe Scientific Reagent Recall is Class 1

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FDA designates a Pointe Scientific recall of liquid glucose hexokinase reagents as a Class 1 recall.

ICH Special Population Q&A Guidance Out

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FDA issues an ICH question-and-answer guidance on use of geriatric patients in clinical databases.