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China Probe Reveals Widespread Data Violations At Major Study Centers

This article was originally published in PharmAsia News

Executive Summary

Severe adverse events left unreported, critical data gone missing, subject drugs substituted to pass bioequivalent testing - these are just some of the wrongdoings disclosed by the China FDA in a rare new report on regulatory transgressions. The irregular practices could well be just the tip of the iceberg as the agency strives to root out data integrity violations at some of the nation's top hospitals.



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