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Alternative Media More Important to DTC Marketers

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Manhattan Research says alternative media will continue to become a larger share of the DTC media and marketing strategy mix.

TAP Backs Prostate Cancer Football Tie-in

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The Prostate Cancer Education Council teams with TAP in a program to increase the number of men screened for prostate cancer.

Workshop on Adolescent OTC Drug Use

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Federal Register Notice: FDA, NIH, and the Consumer Healthcare Product Association plan a public workshop 12/6-7 on adolescent OTC...

Panel to Discuss Genentechs Avastin

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Federal Register Notice: FDAs Oncologic Drugs Advisory Committee will meet 12/5 to discuss Genentechs supplemental BLA for Avastin...

Cultured Epidermal Autografts Must Be Tracked

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FDA adds cultured epidermal autografts to the list of medical devices that must be tracked.

FDA Selects Risk Communication Panel Members

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FDA selects 15 panel members for its newly formed Risk Communication Advisory Committee, whose duties will begin early next year.

Prasugrel Gains Offset by Bleeding Patients

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Researchers comparing Lillys prasugrel to Plavix say prasugrel prevents as many deaths from heart disease as it causes deaths from...

Big Process Validation Remake Coming for Drugs

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CDER deputy compliance director Joseph Famulare says the agencys soon-to-be-published Process Validation Guidance builds validatio...

FDA Says Glaxo Depression Drug Not Approvable

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FDA sends Fabre-KramerPharmaceuticals and GlaxoSmithKline a not-approvable letter for their NDA for gepirone extended-release tabl...

FDA Extends User Fee Date on Sular Formulation

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FDA extends by two months its user fee action date on a SkyePharma PLC supplemental NDA on a new Sular (nisoldipine) formulation.