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Out of the U.S. No Oversight Necessary?

Today the OIG posted “Challenges to FDA’s Ability To Monitor and Inspect Foreign Clinical Trials” (OEI-01-08-00510). As all new investigational drugs and biologics must undergo clinical trials on human subjects to demonstrate safety and efficacy prior to approval for sale in the United States, pharmaceutical manufacturers sponsor trials involving investigators and patients both inside and outside the United States. The data in support of  a particular product’s approval t read more

Full post as published by Pharma 101 - Pharmaceutical Fraud on June 23, 2010 (boomark / email).