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Session 20: Post-NDA Approval Regulatory Requirements
Session Chair(s)
Michael Hamrell, PhD, RAC
President
MORIAH Consultants, 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
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