US FDA slow in debarring clinical investigators, should extend authority to devices
This article was originally published in RAJ Devices
Executive Summary
The US Food and Drug Administration fails to debar quickly enough clinical investigators convicted of contravening medical product regulations from engaging in research, a Government Accountability Office report has revealed1. The report also calls for the FDA’s debarment authority to be extended to medical devices so that it is consistent with the agency’s debarment authority for drugs and biologics; the agency’s current debarment authority does not fully extend to involvement with medical devices.