An FDA application that permits a company to start human clinical trials for a new compound.IND submission requires sufficient preclinical data (safety pharmacology, toxicology, manufacturing) to justify exposing humans to the compound. IND approval is not drug approval — it is permission to conduct research in humans. A compound with IND status is in Phase I or later clinical trials. IND status means regulatory-standard preclinical data exists; it does not mean the compound is safe or effective.