Title: Investigational New Drug (IND) Application and Clinical Investigation Policy Introduction and Purpose: The conduct of clinical investigations (clinical trials) under an FDA-Regulated Investigational New Drug (IND) application involves compliance with a complex set of FDA regulations, requirements, and responsibilities. The FDA holds the IND application sponsor accountable for ensuring compliance with these regulations (21 CFR Part 312, Subpart D). While pharmaceutical companies are typical IND sponsors, individuals, governmental agencies, and academic institutions may also serve as sponsors (21 CFR Part 312.3). This policy serves the following purposes: To assist in determining when an IND is necessary. To provide guidance and resources for individuals conducting clinical investigations, including sponsor-investigators, on obtaining an IND for the investigational drug. To outline the process for compassionate use (expanded access) and emergency use of investigational drugs. Defi...