FDA Approval

The process by which the U.S. Food and Drug Administration evaluates a new drug or biologic for safety and efficacy before it can be legally marketed. FDA approval requires successful completion of preclinical studies and Phase I-III clinical trials, followed by submission of a New Drug Application (NDA) or Biologics License Application (BLA). The review process typically takes 6-12 months after submission. Many peptides studied in research settings have not undergone or completed this approval process.