Preclinical Clinical NDA Review Postmarketing Research and Research and development Surveillance development Initial synthesis Adverse and reaction characterization reporting Phase 1 Phase 2 Surveys sampling Phase 3 testin Animal testing Short-term Long-term Inspections Average62years Average 7 years Average 12years FDA 30-day safety review NDA submitted IDA approval +Average of approx 15 years from initial synthesis to approval of NDA-+l