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Lilly Mounting Major Byetta DTC Campaign

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Lilly breaks a major DTC campaign for its new injectable diabetes drug Byetta.

Therell Be No Layoffs at FDA

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Consulting editor John Scharmann discounts the threat of layoffs at FDA and labels a commissioners staff memo on this selective op...

Shire Extends Ethmozine End Date

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Shire delays discontinuing Ethmozine until 12/31 to allow time for patients to be switched to a new drug.

Haloperidol Labeling Warning Section Updated

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FDA says labeling for haloperidol has been updated with a new Warning for Torsades de Pointes and QT prolongation associated with ...

FDA Class 1 Recall on MRL/Welch Defibrillators

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FDA classifies a MRL/Welch recall of Allyn AED 20 Automatic External Defibrillators as Class 1 due to the potential for the device...

Huge Changes Seen in New Law on Drug Risks

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Expanding FDA risk evaluation and mitigation requirements will fundamentally change the face of pharma marketing over the next fiv...

No Injunction in Generic Prilosec Case

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A judge says FDA had no choice but to convert its approval of an Apotex ANDA for generic Prilosec from final to tentative after an...

FDA Beefing Up its External Communications Efforts

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FDA regulatory policy director Jarilyn DuPont describes a comprehensive effort to improve agency communications with consumer, pro...

FDA Launches Drug Safety Newsletter

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FDA publishes the first issue of its new quarterly online Drug Safety Newsletter, focusing on Genentechs Rituxan, Cephalons Provig...

Quality Problems Found at Danmar Plant

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FDAs Detroit District Office warns Danmar Products about Quality System and device listing violations.