戻る Agenda
Part 4: Post-NDA Approval Regulatory Requirements
Session Chair(s)
Karen K. Church, PHD
Principal
Coachella Valley Regulatory Group, United States
- Post-NDA approval obligations
- Postmarketing (Phase 4) 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
- FDA’s Drug Registration and Listing System (DRLS)