IND Submission

An IND (Investigational New Drug) submission is a regulatory step where a pharmaceutical company requests permission from health authorities, like the FDA, to start testing a new drug in humans. It includes data from laboratory and animal studies showing the drug's safety and how it works. This process ensures that the medication is reasonably safe to begin clinical trials and helps protect participants. Once approved, the company can legally conduct controlled studies to further evaluate the drug’s safety and effectiveness before seeking approval to market it widely.