01 May 2012

FDA Issues Final Rule on Clinical Investigator Disqualification

The U.S. Food and Drug Administration (FDA) announced an amendment that will expand the scope of clinical investigator disqualification.  Under this new regulation, if the FDA Commissioner determines that a clinical investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator will also be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA.  This final rule is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA.  This rule will become effective May 30, 2012.

The final rule is available using the following web link: 

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