No.82 September 19, 2011

(New drug application (NDA)) Review report
Report on the deliberation results
Clinical trial (study) report
Summary technical documentation (STED)
Application for marketing approval; new drug application (NDA)
Application dossier
Summary basis of approval (SBA)

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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