Drug Evaluation Committee Translation: FDA Guidance on RWD
Medical Information DBTF
November 2024
This document was prepared based on the translation of the guidance provided by the AMED Nakamura Group "Research on the Utilization of Medical Information Databases for Pharmaceutical Procedures such as Clinical Outcome Evaluation in the Approval Process of Drugs", which was reviewed and translated by the members of the TF ST2 for the Promotion of Medical Information DB Utilization of the Pharmaceutical Manufacturers Association of Japan. We would like to thank Dr. Ishizuka, Dr. Ohba, Dr. Ishiguro, and Dr. Nakamura for providing the translations.
ST2 is working to promote the use of real-world data and is working with the FDA guidance "Submitting documents using real-world data and real- The translations of the FDA guidance "Submitting documents using real-world data and real- world evidence to FDA for drugs and biologics" and "Considerations for the use of RWD and RWE to Support Regulatory Decision-Making for Drug and Biological The translations of "RWD/RWE and real-world evidence to FDA for drugs and biologics" and "Considerations for the use of RWD and RWE to Support Regulatory Decision-Making for Drug and Biological Products" are expected to improve understanding of the use of RWD/RWE in US regulatory applications and to be helpful for use in Japan.
Published November 2024
Committee on Drug Evaluation, Japan Pharmaceutical Manufacturers Association
TF ST2 for Promotion of Utilization of Medical Information DB
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