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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Detalles Bibliográficos
Autores principales: Mostaghim, Sana R, Gagne, Joshua J, Kesselheim, Aaron S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2017
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5588044/
https://www.ncbi.nlm.nih.gov/pubmed/28882831
http://dx.doi.org/10.1136/bmj.j3837

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5588044/
https://www.ncbi.nlm.nih.gov/pubmed/28882831
http://dx.doi.org/10.1136/bmj.j3837

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