Related Experiment Videos
Investigational drugs and research
1Office of Research Administration, Illinois State Psychiatric Institute, Chicago.
Psychiatric Medicine
|January 1, 1991
Abstract:
This chapter will define investigational use for clinicians and outline FDA policies in this area in a simple and pragmatic way. Instances in which investigational use would require application to the FDA for an investigational New Drug Exemption (IND) and instances in which their use would require approval by an Institutional Review Board (IRB) will be described and examples given.