title: Investigational drugs and research.
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.
authors.affiliation: Office of Research Administration, Illinois State Psychiatric Institute, Chicago.
authors.forename: P
authors.initials: P
authors.lastname: Tueting
mesh_terms: D015507:Drugs, Investigational / Q000592:standards; D006801:Humans; D011367:Professional Staff Committees / Q000592:standards; D012106:Research / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
chemical_list: D015507:Drugs, Investigational