Draft Guidance for Industry and Clinical Investigators on the Use of Clinical Holds Following Clinical Investigator Misconduct; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and clinical investigators entitled "The Use of Clinical Holds Following Clinical Investigator Misconduct." This draft guidance provides information on FDA's use of its authority to impose a clinical hold on a study if FDA finds that a clinical investigator conducting the study has committed serious violations of our regulations pertaining to clinical trials involving human drug or biological products or has submitted false information to FDA or to the study's sponsor in any report. The draft guidance is intended to inform interested persons of the circumstances in which we may impose a clinical hold following the discovery of a clinical investigator's misconduct and the steps we might take to protect human subjects from investigator misconduct.