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DewDiligence

04/13/17 7:28 PM

#210613 RE: DewDiligence #200851

Re: Fake data /China’s drug-approval process

http://www.fiercebiotech.com/cro/china-to-tighten-rules-against-faking-clinical-trial-data-criminal-charges-possible

According to the CFDA’s proposal, if a trial sponsor is found using fabricated data for drug registration, the agency won’t accept its NDA application for drugs in that same category for three years, as well as all NDAs for a year.

This seems like an inordinately light punishment for the crime in question.