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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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.…




