REGULATORY
PMDA to Provide Prior Assessment Consultation Service for 10 APIs in FY2011
At the second meeting of the NDA review and safety assurance activity monitoring committee on December 20, the Pharmaceuticals and Medical Devices Agency (PMDA) revealed that it plans to provide prior assessment consultation services, which was introduced in FY2009, for…
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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…





