Full course description
The conduct of a clinical investigation (i.e., clinical trial) under an FDA-Regulated Investigational New Drug (IND) application includes a complex set of FDA regulations, requirements, and obligations. The FDA holds the sponsor of the IND application responsible for ensuring that all of the regulations, requirements, and obligations are being met (21 CFR Part 312, Subpart D). Although sponsors of IND applications are typically pharmaceutical companies, the FDA regulations governing IND applications permit the Sponsor to be an individual, governmental agency, or academic institution (21CFR Part 312.3).
The purpose of this policy is to:
- help determine when an IND is required,
- provide guidance and resources to individuals conducting a clinical investigation, who may be sponsor-investigators, on obtaining an IND for the drug under study, and
- address the process for compassionate use (also referred to as expanded access) and emergency use of an investigational drug.