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戻る Agenda
Session 22: Post-NDA Approval Regulatory Requirements
Session Chair(s)
Carol H. Danielson, DrPH, MS, RAC
President
Regulatory Advantage, LLC, United States
- Post-NDA Approval Obligations
- Post-Marketing Requirements and Commitments
- Supplements and Other Changes to an Approved Application
- Post-Marketing Reporting
- NDA Annual Reports
- Other Post-Marketing Reports