Investigational New Drug Application (IND)

An Investigational New Drug Application (IND) is a formal request submitted to the Food and Drug Administration (FDA) in the United States, allowing a pharmaceutical company to start testing a new drug in humans. This application includes data on the drug's safety, manufacturing processes, and proposed study plans. The IND ensures that the drug is tested responsibly and ethically, protecting the participants involved in the trials. If the FDA approves the IND, the company can proceed with clinical trials to gather more information about the drug’s effectiveness and safety before seeking full approval for public use.