REGULATORY
PMDA Considering Review Procedure Policy for IVD Agents Based on FDA Guidance Draft
Regarding ongoing requirements to enhance the review system for in vitro diagnostic (IVD) agents aimed at promoting personalized healthcare, Pharmaceuticals and Medical Devices Agency (PMDA) Deputy Review Director Daisei Miyamoto (Office of Medical Devices II) revealed at a lecture held…
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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…





