During drug development, companies must submit an Investigational New Drug (IND) application to regulatory bodies like the FDA before beginning clinical trials in humans. The IND application includes data from toxicology studies to demonstrate the drug's safety for initial testing in humans. After successful clinical trials, a New Drug Application (NDA) is submitted to gain approval for marketing the drug. The NDA includes comprehensive data on the drug's efficacy and safety, including results from toxicology studies.
