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www.fdanews.com/articles/127312-drugmakers-ask-fda-to-draw-line-between-fraud-error-in-regulation

Drugmakers Ask FDA to Draw Line Between Fraud, Error in Regulation

May 24, 2010
Drug companies and trade associations are asking the FDA to be more specific in distinguishing between simple human error and intentionally falsified data that would be subject to a proposed rule requiring stricter reporting guidelines for investigators who fabricate research data. The companies’ requests were included in comments on the proposed rule. Sponsors who learn their clinical trial data or its analysis may have been falsified would be required to report the information to the FDA within 45 days.
Drug Industry Daily