<scp>PMDA</scp> Perspective on <scp>RWD</scp>/<scp>RWE</scp> Utilization for Regulatory Purposes Including Assessment on the Impacts of Regulatory Actions and Safety Risk of a Drug at Postmarketing Stage-Reference-Cited by-同舟云学术

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PMDA Perspective on RWD/RWE Utilization for Regulatory Purposes Including Assessment on the Impacts of Regulatory Actions and Safety Risk of a Drug at Postmarketing Stage

Published:2024-09 Issue:9 Volume:33 Page:
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiology and Drug

Author:

Kajiyama Kazuhiro¹²,Komamine Maki¹^ORCID,Horiuchi Naoya¹,Iguchi Toyotaka³,Uyama Yoshiaki⁴^ORCID

Affiliation:

1. Office of Pharmacovigilance I Pharmaceuticals and Medical Devices Agency Tokyo Japan

2. Office of Regulatory Science Research, Center for Regulatory Science Pharmaceuticals and Medical Devices Agency Tokyo Japan

3. Office of Pharmacovigilance II Pharmaceuticals and Medical Devices Agency Tokyo Japan

4. Center for Regulatory Science Pharmaceuticals and Medical Devices Agency Tokyo Japan

Publisher

Wiley

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.70007

Reference16 articles.

1. Contribution of Real‐World Evidence in European Medicines Agency's Regulatory Decision Making

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

3. The Role of Real‐World Evidence in FDA‐Approved New Drug and Biologics License Applications

4. Six Years of the US Food and Drug Administration's Postmarket Active Risk Identification and Analysis System in the Sentinel Initiative: Implications for Real World Evidence Generation

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