Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018

This cross-sectional study compares the duration of postapproval trials with that of the pivotal trials used as the basis for the US Food and Drug Administration’s (FDA’s) approval for all indications receiving accelerated approval from 2009-2018.

Detalles Bibliográficos
Autores principales: Wallach, Joshua D., Ramachandran, Reshma, Bruckner, Till, Ross, Joseph S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2021
Materias:
Research Letter
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8579231/
https://www.ncbi.nlm.nih.gov/pubmed/34751764
http://dx.doi.org/10.1001/jamanetworkopen.2021.33601

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8579231/
https://www.ncbi.nlm.nih.gov/pubmed/34751764
http://dx.doi.org/10.1001/jamanetworkopen.2021.33601

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