Application to the Food and Drug Administration (FDA) seeking approval to begin clinical studies of a new pharmaceutical.
A drug available solely for experimental purposes intended to determine its safety and effectiveness and not yet approved by the FDA for marketing to the general public. Prescription of the drug is limited to those experts qualified by training and experience to investigate its safety and effectiveness. Use of the drug in humans requires approval by the FDA of an IND application which provides reports of animal toxicity tests, a description of proposed clinical trials, and a list of the names and qualifications of the investigators.
A drug available only for experimental purposes because its safety and effectiveness have not been proven.