An Investigational New Drug (IND) application is a regulatory submission to the U.S. Food and Drug Administration (FDA) requesting authorization to begin testing a new drug or biologic in humans. The IND process allows sponsors to ship an investigational product across state lines and initiate clinical trials while the product remains under investigation.
An IND application includes preclinical data, manufacturing information, clinical trial protocols, and investigator qualifications to demonstrate that the investigational product can be studied safely in human participants. FDA review focuses on participant safety, scientific rationale, and whether the proposed clinical investigation is appropriate to proceed.
INDs are commonly required for studies involving investigational drugs, biologics, gene therapies, and certain combination products. Sponsors must maintain the IND throughout the study lifecycle by submitting protocol amendments, safety reports, and annual updates to the FDA. Investigators, IRBs, and oversight committees rely on IND-related documentation to assess participant protections, risk mitigation strategies, and regulatory compliance.