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Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model

Real world evidence (RWE) and real-world data (RWD) are drawing ever-increasing attention in the pharmaceutical industry and drug regulatory authorities (DRAs) all over the world due to their paramount role in supporting drug development and regulatory decision making. However, there is little syste...

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Detalhes bibliográficos
Publicado no:Front Med (Lausanne)
Main Authors: Li, Meng, Chen, Shengqi, Lai, Yunfeng, Liang, Zuanji, Wang, Jiaqi, Shi, Junnan, Lin, Haojie, Yao, Dongning, Hu, Hao, Ung, Carolina Oi Lam
Formato: Artigo
Idioma:Inglês
Publicado em: Frontiers Media S.A. 2021
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC8200400/
https://ncbi.nlm.nih.gov/pubmed/34136505
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.3389/fmed.2021.669509
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