Evolving Acceptance and Use of RWE for Regulatory Decision Making on the Benefit/Risk Assessment of a Drug in Japan-Reference-Cited by-同舟云学术

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

Published:2021-09-18 Issue:1 Volume:111 Page:35-43
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Nishioka Kinue¹,Makimura Tomomi²,Ishiguro Akihiro³,Nonaka Takahiro⁴,Yamaguchi Mitsune⁵,Uyama Yoshiaki⁴

Affiliation:

1. Office of New Drug III Pharmaceuticals and Medical Devices Agency Tokyo Japan

2. Office of Standards and Compliance for Medical Devices Pharmaceuticals and Medical Devices Agency Tokyo Japan

3. Office of Research Promotion Pharmaceuticals and Medical Devices Agency Tokyo Japan

4. Office of Medical Informatics and Epidemiology Pharmaceuticals and Medical Devices Agency Tokyo Japan

5. Office of Non‐clinical and Clinical Compliance Pharmaceuticals and Medical Devices Agency Tokyo Japan

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2410

Reference37 articles.

1. Real-World Evidence — What Is It and What Can It Tell Us?

2. Real‐World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe

3. US Food and Drug Administration.Framework for FDA's Real‐World Evidence Program (2018). Accessed August 12 2021.

4. US Food and Drug Administration.Guidance for industry and FDA staff: best practices for conducting and reporting pharmacoepidemiologic safety studies using electronic healthcare data (2013). Accessed August 12 2021.

5. US Food and Drug Administration.Draft guidance for industry: submitting documents using real‐world data and real‐world evidence to FDA for drugs and biologics (2019). Accessed August 12 2021.

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