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.
With the computing power available, we can speed up the process of collecting and disseminating data to save valuable time for life sciences manufacturers.