China Clarifies Position on Forged Trial Data As 30 Applications Are Rejected
As more new drug applications get rejected under the China Food and Drug Administration’s drive to stamp out trial data forgery, the regulator has issued draft guidance to clarify its position on data integrity breaches.
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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 Food and Drug Administration in a rare report on regulatory transgressions during drug trials conducted in the country.
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