返回 Agenda
Session 20: Post-NDA Approval Regulatory Requirements
Session Chair(s)
Elliott Berger, PhD, MS
President
ETB Regualtory Consulting, United States
- Post-NDA approval obligations
- Postmarketing (Phase 4) requirements and commitments
- Supplements and other changes to an approved application
- Postmarketing reporting of adverse drug experiences
- 15-Day Alert Reports
- NDA Annual Reports
- NDA Field Alert Reports
- Biologic Product Deviation Reports
- Drug registration and listing