Drug Evaluation Committee Scientific Discussion on FDA Review Report
Data Science Expert Committee
September 2025
While projects for individual development items provide opportunities to experience interactions and correspondence with regulatory authorities (or multiple regulatory authorities for international co-development), there are not many opportunities to learn in detail what scientific discussions took place in other projects or at other companies that led to the final decisions. 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 Drug Evaluation Committee
Data Science Subcommittee 2024 Task Force 5