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戻る Agenda
Sessions 18, 19, and 20
Session Chair(s)
Albert S. Yehaskel, MBA
President and CEO
Refuah Global Pharmaceutical Development, Inc., United States
Session 18 : The NDA Labels
- The NDA Labels
- Immediate Container Label
- Carton Label
- Components of a Global Development Plan
- Manufacturing Strategy (CMC Development Plan)
- Risks and Issues
- Strategies for Meeting with FDA
- Planning and Important Documents for a CM&C Meeting
- Meeting Request Letter
- The Briefing Document
- Regulatory Mechanism for an FDA Meeting
- Preparing for the Meeting, Rehearsals; During the Meeting
- Types of Meetings Encountered During Drug Development