Investigational New Drug (IND) Applications

An Investigational New Drug (IND) Application is a formal request submitted to the U.S. Food and Drug Administration (FDA) by a pharmaceutical company seeking permission to begin human clinical trials for a new drug. It contains data on the drug’s safety, manufacturing, and proposed study protocols. The application ensures that the drug’s testing process is safe for participants and meets regulatory standards. If approved, researchers can start trials to gather evidence on the drug’s effectiveness and safety before it can be considered for broader public use.