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Home » EU Offers Step-by-Step Guidance on New Pharmacovigilance Regs
EU Offers Step-by-Step Guidance on New Pharmacovigilance Regs
May 2, 2012
Drugmakers should have a structured and recognized methodology for assessing evidence in an adverse reaction report, taking into account such factors as clinical relevance, quantitative strength of the association and the exposure-response association, according to a draft European Medicines Agency (EMA) guideline.