Upon filing of a new drug application (NDA; 承認申請), the Pharmaceuticals and Medical Devices Agency (PMDA; 医薬品医療機器総合機構) forms a team of reviewers (審査官) specialized in pharmaceutical and medical sciences, physics, chemistry, biostatistics and all other fields appropriate for reviewing the...
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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…




