Spontaneous reporting of post-market safety signals: what evidence should support regulatory action?

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). 1 2 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.