Overview of the Premarketing and Postmarketing Requirements for Drugs Granted Japanese Conditional Marketing Approval

• Main Authors: Shunsuke Matsushita (Author), Keisuke Tachibana (Author), Tetsuya Kusakabe (Author), Ryuichi Hirayama (Author), Yasuo Tsutsumi (Author), Masuo Kondoh (Author)
• Format: Book
• Published: Wiley, 2021-05-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

For drugs that are intended to fill unmet medical needs, such as the treatment of rare diseases or a subtype of cancer, it can take a long time to conduct confirmatory clinical trials due to limited patient availability. Delayed access to these drugs increases the risk of mortality of patients with...