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Evolving Acceptance and Use of RWE for Regulatory Decision Making on the Benefit/Risk Assessment of a Drug in Japan

There is growing interest in the utilization of real‐world data (RWD) and real‐world evidence (RWE) for regulatory purposes. However, there are challenges in the practical utilization of RWD to provide RWE as a basis for regulatory decision making. This article presents the regulatory initiatives in...

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Detalles Bibliográficos
Autores principales:	Nishioka, Kinue, Makimura, Tomomi, Ishiguro, Akihiro, Nonaka, Takahiro, Yamaguchi, Mitsune, Uyama, Yoshiaki
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2021
Materias:	Reviews
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9290512/ https://www.ncbi.nlm.nih.gov/pubmed/34528701 http://dx.doi.org/10.1002/cpt.2410

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