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China FDA Expands Clinical Data Witch Hunt To CROs, Study Sites

This article was originally published in PharmAsia News

Executive Summary

Drug manufacturers in China were firstly required to conduct self-audits of the clinical data submitted to support their product approval applications, then clinical sites were asked to improve study oversight. Now, contract research organizations seem to have become the latest target as the China FDA expands a crackdown on clinical data forgery in which it seemingly considers a 20% failure rate not sufficient.

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