drug approval timeline

The drug approval timeline involves several key stages. First, researchers conduct laboratory tests and animal studies to assess safety. If results are promising, they submit an Investigational New Drug (IND) application to regulatory authorities, like the FDA in the U.S. Clinical trials then begin, conducted in three phases to test safety and effectiveness in humans. After successful trials, a New Drug Application (NDA) is submitted for review. Approval can take months to years, depending on the drug's complexity and urgency. Once approved, the drug can be marketed, but post-approval monitoring continues to ensure ongoing safety.