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FDA Plans New Safety Assessment Of Boehringer Ingelheim Corporation's Pradaxa


1/3/2014 8:22:54 AM

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This protocol will guide a one-time assessment of selected safety outcomes in adults with atrial fibrillation who are new users of dabigatran or warfarin. Protocol-based assessments use study designs and analysis plans customized for the product-outcome pairs being assessed. The Mini-Sentinel Operations Center has posted this final draft protocol for public comment. Comments must be received by the Mini-Sentinel Operations Center no later than January 13, 2014. Submit comments by clicking on the Submit Comments link above and filling out the Comment Form or by sending an email directly to info@mini-sentinel.org.

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