LEXICON
No.82 September 19, 2011

(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

New drug application (NDA) review reports (審査報告書) are extensive reports that outline the NDA review process and conclusion for each new drug approved in Japan. Review reports are prepared by the Pharmaceuticals and Medical Devices Agency (PMDA; 医薬品医療機器総合機構) and published...

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