The process of FDA approval involves several stages. Initially, preclinical research is conducted, often involving laboratory and animal studies. If these initial studies are promising, the product moves to clinical trials, which are conducted in multiple phases to assess safety, dosage, and efficacy. After successful clinical trials, the product sponsor submits a New Drug Application (NDA) or Biologics License Application (BLA) to the FDA. The FDA then reviews the data and makes a decision on approval.
