A descriptive research: Exclusion from submitted clinical data package in the review process of new drug approval due to GCP violation in Japan
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DOI: 10.1016/j.conctc.2019.100416
Abstract: Introduction In Japan, the PMDA conducted inspections based on GCP in the review process of the submission of NDAs or sNDAs. In this descriptive study, we examined in detail the contents of exclusion data from… read more here.
Keywords: submitted clinical; exclusion; ndas sndas; review process ... See more keywords