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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Elective Care Scheme for LLPs長期収載品 選定療養制度July 19, 2024
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G1/G2 RuleG1/G2ルールMarch 9, 2018
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New PMP Criteria新薬創出加算の新要件March 9, 2018
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Cost-Based Method原価計算方式July 27, 2017
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Sakigake Designation Scheme先駆け審査指定制度August 17, 2016
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…




