Drug Evaluation Committee Scientific Discussion on FDA Review Report
Data Science Subcommittee
September 2025
While each development project for an individual drug product provides opportunities to experience interactions and correspondence with regulatory authorities (or multiple regulatory authorities in the case of international joint development), there are not many opportunities to learn in detail what kind of scientific discussions took place and led to the final decisions in other projects or in the cases of other companies. One way to obtain such information is through the review documents that each regulatory agency makes publicly available. The FDA's documents are particularly useful because they are very comprehensive in terms of both quantity and quality.
In this task force, assuming people involved in clinical trials as the main readers, we introduced examples from the FDA's Review Report and Advisory Committee materials that we thought would make reading the FDA report more meaningful. In addition, we also explain how to find other materials so that you can search and check FDA materials on your own when you have an interest in something other than the case studies introduced here. We hope you will find this information useful as a reference for your own work and research.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Data Science Subcommittee 2024 Task Force 5
Deliverables of the Drug Evaluation Committee Return to list of all deliverables