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

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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Bibliographic Details
Main Authors: Meng Li, Shengqi Chen, Yunfeng Lai, Zuanji Liang, Jiaqi Wang, Junnan Shi, Haojie Lin, Dongning Yao, Hao Hu, Carolina Oi Lam Ung
Format: Article
Language:English
Published: Frontiers Media S.A. 2021-05-01
Series:Frontiers in Medicine
Subjects:
regulatory science
real-world evidence
decision-making
logic model
regulation
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2021.669509/full

Internet

https://www.frontiersin.org/articles/10.3389/fmed.2021.669509/full

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