Introduced for the first time in April 2009 on a trial basis, the prior assessment consultation system is expected to be very effective for shortening time required for NDA (new drug application) review. Data on CMC (chemistry, manufacture and control),...
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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…




