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CFDA Requires Drugmakers to Verify Clinical Trial Data Filings

publication date: Jul 30, 2015
In a dramatic announcement, the CFDA declared it will hold drugmakers responsible for the accuracy of their clinical trial data. The agency gave companies one month, until August 22nd, to conduct self-inspections and verify their current clinical trial data filings, according to a report by US-Asia healthcare law firm Sidley Austin. If the companies discover any discrepancies, they can withdraw their data without any penalties. Once the deadline is passed, the CFDA will begin making unannounced spot inspections. If the CFDA discovers discrepancies, it may level fines and penalties, up to a three-year prohibition of any new drug filings to the CFDA. More details....

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