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戻る Agenda
Module 5: Phase 3 and Regulatory Review (continued)
Session Chair(s)
Courtland R. LaVallee, MBA
Executive Director, Project Management
Dynavax Technologies, United States
- NDA Preparation
- Review Clock
- FDA Questions/Requests for Data
- Label Negotiation Centralized Procedure
- De-centralized Procedure
- Mutual Recognition
- Devices