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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...
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 |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2023
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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 |
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