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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A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…





