The regulatory approval process typically involves several stages:
Preclinical Studies: Laboratory and animal studies to gather initial efficacy and safety data. Investigational New Drug (IND) Application: Submission to regulatory bodies before human trials can begin. Clinical Trials: Conducted in three phases to assess safety, dosage, and efficacy in humans. New Drug Application (NDA) or Biologics License Application (BLA): Comprehensive submission of all data for regulatory review. Post-Marketing Surveillance: Ongoing monitoring for long-term effects and adverse reactions.
