An Investigational New Drug (IND) is a designation given by the U.S. Food and Drug Administration (FDA) to a new pharmaceutical compound that is being tested for safety and effectiveness in humans. Before a drug can be marketed, it must undergo a series of clinical trials to gather data on its effects, side effects, and optimal dosages. The IND process begins after preclinical testing, which involves laboratory and animal studies. Once a sponsor submits an IND application, the FDA reviews it to ensure that the proposed studies are ethical and that participants will be protected. If approved, the drug can enter clinical trials, moving closer to potential public availability.