U.S. Department of Health and Human ServicesFood and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
March 2005
Clinical Medical
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).2 Specifically, this document provides guidance on (1) safety signal identification, (2) pharmacoepidemiologic assessment and safety
signal interpretation, and (3) pharmacovigilance plan development.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should
be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or
recommended, but not required.
drug products (excluding blood and blood components).2 Specifically, this document provides guidance on (1) safety signal identification, (2) pharmacoepidemiologic assessment and safety
signal interpretation, and (3) pharmacovigilance plan development.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should
be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or
recommended, but not required.
No comments:
Post a Comment
Please feel free to contact or comment the article