Disqualification of a clinical investigator--FDA. Final rule.
The Food and Drug Administration (FDA) is amending the investigational new drug regulation that provides for disqualification of clinical investigators who submit false information. The revision is intended to clarify the agency's authority to reach sponsor-investigators under the regulation.
D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005607:Fraud / Q000331:legislation & jurisprudence*; D017387:Investigational New Drug Application / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration