Investigational New Drug Application Form

An Investigational New Drug (IND) Application is a formal request submitted to the U.S. Food and Drug Administration (FDA) before beginning clinical trials of a new drug. It provides detailed information about the drug’s composition, manufacturing process, and results from preclinical studies, showing that it is reasonably safe to test in humans. The purpose of the IND is to ensure that the drug is tested responsibly and ethically, protecting participants’ safety while allowing scientists to study its effectiveness for treating medical conditions. Once approved, researchers can proceed with clinical trials involving human subjects.