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    FDA Guidance: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment

    March 26, 2005
    This document provides guidance to industry on good pharmacovigilance practices and pharmacoepidemiologic assessment, specifically on (1) safety signal identification, (2) pharmacoepidemiologic assessment and safety signal interpretation, and (3) pharmacovigilance plan development.
    To download this 23-page PDF document, click the "Download Now" button below.
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