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).12 Identifying drug safety issues after regulatory approval is common; th...

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Bibliographic Details
Published in:BMJ (Online) 2022-10, Vol.379, p.o2409-o2409
Main Authors: Dhodapkar, Meera M., Ross, Joseph S., Ramachandran, Reshma
Format: Article
Language:English
Subjects:
Health surveillance
Opinion
Patient safety
Pharmacovigilance
Regulatory agencies
Safety
Side effects
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Summary: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
ISSN:1756-1833
1756-1833
DOI:10.1136/bmj.o2409