An Investigational New Drug Application (IND) is a regulatory submission that allows an investigational drug or biological product to be administered to humans as part of a clinical investigation in the United States.
In clinical research, an IND provides the FDA with information needed to evaluate whether a proposed investigation can proceed, including data on the investigational product, manufacturing information, preclinical findings, and the clinical protocol. IND requirements help protect research participants while supporting the clinical development of new drugs and biologics. Studies conducted under an IND are subject to applicable FDA requirements as well as institutional review board (IRB) review and informed consent requirements.