(New drug application (NDA)) Review report審査報告書Report on the deliberation results審議結果報告書Clinical trial (study) report治験総括報告書Summary technical documentation (STED)申請資料概要Application for marketing approval; new drug application (NDA)製造販売承認申請書Application dossier申請資料Summary basis of approval (SBA)新医薬品承認審査概要
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