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Human Subjects Division (HSD)

Regulatory Updates

FDA Proposes New Rule on Disqualification of a Clinical Investigator

Apr 13, 2011 at 9:33am
Good Clinical Practice/Human Subject Protection Update

The Food and Drug Administration is proposing to amend its regulations to expand the scope of clinical investigator disqualification. Under this proposal, when the Commissioner of Food and Drugs determines that an investigator is ineligible to receive certain test articles (drugs, devices, or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA.

The proposed rule is now available using the following web link: http://www.gpo.gov/fdsys/pkg/FR-2011-04-13/pdf/2011-8786.pdf

Comments to this proposed rule are due by July 12, 2011.