What exactly does a new medication have to go through to become fda approved?

To become FDA approved, a new medication must undergo a rigorous process that includes several phases of clinical trials. Initially, the drug is tested in laboratories and on animals to assess its safety and effectiveness. Following this, it enters human trials, which are conducted in three phases to evaluate its safety, efficacy, and optimal dosing. After successful trials, the drug's manufacturer submits a New Drug Application (NDA) to the FDA, which reviews the data before granting approval if the benefits outweigh the risks.