FDA finalizes the regulatory change to expand the scope of clinical investigator disqualification

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FDA finalized the regulatory change to expand the scope of clinical investigator disqualification effective May 30, 2012. Under the new ruling, when the Commissioner determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also becomes ineligible to conduct any clinical investigation that supports an application for research or marketing permit for other kinds of products regulated by FDA. This stricter enforcement was recommended by the GAO, which concluded that it is “critical for FDA to take action-and to have the authority to take action to prevent clinical investigators who engaged in serious misconduct from doing so again, whether in research that involves drugs, biologics, or devices.”

Read the new regulations here.