IND Application Process

An Investigational New Drug (IND) application is a formal proposal submitted to regulatory authorities (like the FDA) to begin testing a new drug in humans. It includes data from lab and animal studies showing the drug's safety, as well as plans for clinical trials. The review ensures the proposed trials won’t pose unreasonable risks. Once approved, the sponsor can start testing the drug in humans to assess its safety and effectiveness. The IND process is crucial for protecting participants and ensuring rigorous evaluation before any new drug reaches the market.