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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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…




