IND submission process

An Investigational New Drug (IND) submission is a request to regulatory authorities, like the FDA, to start testing a new drug in humans. It includes data from lab and animal studies showing the drug's safety and how it works. The goal is to ensure the drug is reasonably safe before testing in people. Once submitted, the agency reviews the information, typically within 30 days, and if it’s good, the researchers are cleared to proceed with clinical trials to evaluate the drug’s safety and effectiveness in humans.