Investigational New Drug Application

An Investigational New Drug (IND) application is a request submitted to regulatory authorities, like the U.S. FDA, before starting clinical trials of a new drug in humans. It provides detailed information about the drug's laboratory testing, manufacturing process, and how it will be tested in people. The purpose is to ensure the drug is reasonably safe and that the clinical trials are well-designed. Once approved, researchers can begin testing the drug in volunteers to evaluate its safety and effectiveness before seeking full approval for widespread use.