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Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment Guidance for Industry March 2005

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This document provides guidance to industry on good pharmacovigilance practices andpharmacoepidemiologic assessment of observational data regarding drugs, including biologicaldrug products (excluding blood and blood components). Specifically, this document providesguidance on (1) safety signal identification, (2) pharmacoepidemiologic assessment and safetysignal interpretation, and (3) pharmacovigilance plan development.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.