The FDA regulates prescription drug approval through a multi-stage process, starting with pre-clinical trials and an Investigational New Drug (IND) application to begin human testing [1]. Following successful, three-phase clinical trials, sponsors submit a New Drug Application (NDA) for approval, which requires rigorous documentation on safety, efficacy, and manufacturing quality [1]. The process continues after approval with post-market surveillance, requiring pharmaceutical companies to monitor for long-term adverse events and ensure continuous compliance with manufacturing standards [1]. Learn more about navigating this complex regulatory landscape directly from the FDA's guidelines.