Comparison of novel oncology drugs that received dual approval from the US accelerated approval and EU conditional marketing authorisation pathways, 2006–2021: a cross-sectional study

OBJECTIVE: We aimed to provide insight into differences in drug review decisions made by the US Food and Drug Administration’s (FDA) accelerated approval (AA) pathway and the European Medicines Agency’s (EMA) conditional marketing authorisation (CMA) pathway, and to add to the current knowledge base...

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Detalles Bibliográficos
Autores principales: Xie, Jinping, Li, Jinlian, Liu, Yue, Wang, Haoyang, Wang, Yifei, Yang, Yifan, Chen, Yi, Jiang, Rong, Shao, Rong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Health Policy
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10255285/
https://www.ncbi.nlm.nih.gov/pubmed/37286329
http://dx.doi.org/10.1136/bmjopen-2022-069132

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10255285/
https://www.ncbi.nlm.nih.gov/pubmed/37286329
http://dx.doi.org/10.1136/bmjopen-2022-069132

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