Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study

Objective To determine if drugs approved through the Food and Drug Administration’s expedited development and review pathways have different rates of safety related label changes after approval compared with drugs approved through standard non-expedited pathways. Design Retrospective cohort study. S...

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Bibliographic Details
Published in:BMJ
Main Authors: Mostaghim, Sana R, Gagne, Joshua J, Kesselheim, Aaron S
Format: Artigo
Language:Inglês
Published: BMJ Publishing Group Ltd. 2017
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Research
Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC5588044/
https://ncbi.nlm.nih.gov/pubmed/28882831
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1136/bmj.j3837
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