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.
| 
