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Evidence of pre-approval clinical trial supporting the granted conditional approval for novel cancer drugs in China between 2015 and 2022

BACKGROUND: Accelerated approval (AA) of novel anticancer drugs based on surrogacy has attracted considerable concern globally. China National Medical Products Administration (NMPA) also established a similar conditional approval (CA) program to accelerate the approval of novel drugs to address unme...

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Detalles Bibliográficos
Autores principales: Luo, Xingxian, Du, Xin, Huang, Lin, Guo, Qixiang, Lv, Xufeng, Wang, Cen, Liu, Haopeng, Zhou, Yue, Xue, Xuecai, Li, Zhuangqi, Liu, Jingwen, Chow, Shein-Chung, Yang, Yue
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10474375/
https://www.ncbi.nlm.nih.gov/pubmed/37662522
http://dx.doi.org/10.1016/j.eclinm.2023.102177