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Asia Spotlight: China Probe Reveals Widespread Data Violations At Major Study Centers

 
• By Brian Yang

Severe adverse events left unreported, critical data gone missing, subject drugs substituted to pass bioequivalent testing are just some of the wrongdoings disclosed by the China FDA in a rare new report on regulatory transgressions.

On the second Monday of each month, “The Pink Sheet” provides exclusive news and commentary on the Asia biopharma market from the editors of our affiliated publication PharmAsia News.

BEIJING – When a study subject in a trial for an investigational oncology drug was given a 50% lower dose than required, the subject should have been disqualified for inclusion in accordance with the study design

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