Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment

March 1, 2005 This report, published by the United States Department of Health and Human Services Food and Drug Administration, discusses best practices in the fields of Pharmacovigilance and Pharmacoepidemiology. This document provides guidance to industry on good pharmacovigilance practices and pharmacoepidemiologic assessment of observational data regarding drugs, including biological drug products (excluding blood and blood components). Specifically, this document provides guidance on (1) safety signal identification, (2) pharmacoepidemiologic assessment and safety signal interpretation, and (3) pharmacovigilance plan development. This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. Download the Report . . .