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Regulatory Update

Posted 01 June 2011 | By Michael Matthews 

The US Food and Drug Administration (FDA) has proposed amending existing regulations to prevent disqualified investigators from conducting any type of agency-regulated clinical investigations. Currently, a disqualified investigator may still run clinical investigations with other types of products besides the type for which he or she was disqualified. For example, if an investigator is disqualified from running a trial on pharmaceuticals, they may still run trials on medical devices.


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