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FDA Names Cot to Head Orphan Products

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FDA selects CDC Rwanda country director Timothy Cot as the new director of the agencys Office of Orphan Products Development.

House Passes FDA Revitalization Act

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The House of Representatives passes the FDA Revitalization Act after a House-Senate conference adopts a compromise version of diff...

Drug Ad Violations Up, Biologics Down

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FDA says enforcement trends for violations of advertising/promotion regulations indicate actions against drug advertisers have ris...

FDA Seeks to Boost Consumer Ad Comprehension

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DDMAC calls marketers attention to FDA-funded research projects designed to improve consumer understanding of print and television...

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...