- Showing an actual TV commercial about where and how the lists of side effects is generated
- Adverse Event “Journey”
- Individual Patient Adverse Event (AE) on Case Report Form (CRF)
- AEs in Clinical Study Report (CSR)
- AEs in Integrated Summary of Safety (ISS)
- AEs by Indication in Clinical Safety Summary
- AE/Safety Information - FDA Review of Chantix
- AE of Special Interest - FDA Review of Chantix
- Benefit Risk Assessment
- Prescribing Information
- Prescribing Information - Chantix
- (Partial) AE list in PI
- AE “Journey”
- Purpose of Prescription Drug Product Labelling
Nancy Pire-Smerkanich, DRSc, MS
Associate Director, Regulatory Knowledge and Support