IND (Investigational New Drug) Application

An Investigational New Drug (IND) application is a request submitted to a regulatory authority, such as the U.S. Food and Drug Administration (FDA), seeking permission to begin testing a new drug in humans. Before submitting an IND, researchers conduct laboratory and animal studies to gather initial safety and efficacy data. The application includes information about the drug's composition, manufacturing process, and research protocols. Approval of the IND allows the drug to proceed to clinical trials, where it is tested on volunteers to determine its safety, dosage, and effectiveness before potential approval for public use.