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Ads for Switched Drugs Have Less Risk Info

[ Price : $8.95]

Researchers say that ads for drugs that have been switched to OTC have less risk information than ads for the same drugs when they...

CDRH Aggressively Pursues 'Single Audit Program'

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Office of Compliance director Steve Silverman updates a PDA conference session on the Centers single audit program where a third-p...

FDA Clears GenMark Diagnostics

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FDA clears a GenMark Diagnostics 510(k) application for its eSensor Respiratory Virus Panel, indicated to detect and differentiate...

FDA Gets Level Funding in Agreement

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A congressional continuing resolution says FDA would receive its current level of funding for the next six months.

Actor Promoting Fluzone Intradermal Shots

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Sanofi Pasteur says it is working with actor Chris ODonnell to promote awareness of the need for flu vaccinations in adults and av...

Qualitest Recalls 1 Lot of Hydrocodone Tablets

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FDA says Qualitest is recalling one lot of hydrocodone bitartrate acetaminophen tablets due to the potential for acetaminophen ove...

FDA Will Review New Vyvanse Indication

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FDA says it will review a Shire sNDA for a new Vyvanse indication for maintenance therapy in children and adolescents ages 6-17 wi...

Woodcock: Biosimilars Need Paradigm Shift in Reviews

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CDER director Janet Woodcock says regulation of biosimilars will require a paradigm shift in treatment by reviewers of issues of e...

Sanofi Aventis Aubagio OKd for Multiple Sclerosis

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FDA approves Sanofi Aventis Aubagio for relapsing forms of multiple sclerosis in adults, but with liver-damage and birth defect wa...

FDA Approves Prostate Cancer Imaging Agent

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FDA approves Choline C 11 injection for use in detecting recurrent prostate cancer through PET scans.