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Journal Article
Spontaneous reporting of post-market safety signals: what evidence should support regulatory action?
2022
Overview
A critical component of drug safety monitoring is post-marketing pharmacovigilance, which through a combination of voluntary and active surveillance efforts, provides early identification of potential adverse drug events (AEs).12 Identifying drug safety issues after regulatory approval is common; the US Food and Drug Administration (FDA) initiates a regulatory safety action for approximately one-third of newly approved drugs, on average of four years after approval.3
Publisher
British Medical Journal Publishing Group,BMJ Publishing Group LTD
Subject
