Regulatory Science for Photodynamic Therapy: Analysis of Efficacy and Safety Evaluation for Regulatory Approval in Japan and the USA

Abstract

As a basic study for establishment of methodology of efficacy and safety evaluation of photodynamic therapy (PDT), we reviewed systematically the optimization of therapeutic parameters, pivotal studies and equivalency evaluation of generic devices for PDT in Japan and the USA, and analyzed the current status and issues of efficacy and safety evaluation of PDT. This study clarified the current status of efficacy and safety evaluation of PDT systematically and the future tasks such as development of consensus of therapeutic parameter evaluation, efficient methodology for PDT evaluation and infrastructure for accumulation of clinical evidences.