戻る Agenda
Session 20: Post-NDA Approval Regulatory Requirements
Session Chair(s)
Drusilla Scott, PHD, RAC
Vice President, Regulatory Affairs
Sobi, Inc., United States
Carol H. Danielson, DrPH, MS, RAC
President
Regulatory Advantage, LLC, 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