REGULATORY
PFSB Issues Notification on Marketing Authorization Applications for In Vitro Companion Diagnostics
The Office of Medical Devices Evaluation of the Pharmaceutical and Food Safety Bureau’s (PFSB) Evaluation and Licensing Division issued a notification on February 26 to prefectures regarding matters to keep in mind when submitting applications for the marketing authorization 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…





