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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Detalles Bibliográficos
Autores principales: Li, Meng, Chen, Shengqi, Lai, Yunfeng, Liang, Zuanji, Wang, Jiaqi, Shi, Junnan, Lin, Haojie, Yao, Dongning, Hu, Hao, Ung, Carolina Oi Lam
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Medicine
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8200400/
https://www.ncbi.nlm.nih.gov/pubmed/34136505
http://dx.doi.org/10.3389/fmed.2021.669509

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8200400/
https://www.ncbi.nlm.nih.gov/pubmed/34136505
http://dx.doi.org/10.3389/fmed.2021.669509

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