REGULATORY
Notification Calls for Simultaneous Filing of Applications for Companion Diagnostics and Drugs
The Pharmaceutical and Food Safety Bureau’s Evaluation and Licensing Division issued a notification (Yakushokushinsahatsu 0701 No. 10) to prefectures regarding applications for the approval of companion diagnostics and related medical devices on July 1. The notification clarifies the definition of…
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REGULATORY
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In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





