Drug Evaluation Committee Scientific Discussion on FDA Review Report
September 2025
While working on individual development projects, one has the opportunity to engage with and respond to regulatory authorities (or multiple regulatory authorities in the case of international joint development), but there are few opportunities to gain detailed insight into the scientific discussions that took place and the decision-making processes that led to final decisions in other projects or at other companies. One way to access such information is through the review documents published by each regulatory authority.Among these, the FDA’s documents are particularly comprehensive in both the quantity and quality of information disclosed, making them a valuable resource.
This task force targeted those involved in clinical trials as its primary audience and presented case studies selected from FDA Review Reports and Advisory Committee materials that we believed would help readers better appreciate the value of reading FDA reports.In addition, we have provided instructions on how to search for these materials so that you can independently locate and review FDA documents should you develop an interest beyond the examples presented. Please use this information as a reference for your work and research.
Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee
Data Science Subcommittee FY2024 Task Force 5