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戻る Agenda
Session 14: The NDA: Planning, Content, Types of NDAs/BLAs, and Exclusivity
Session Chair(s)
Carol H. Danielson, DrPH, MS, RAC
President
Regulatory Advantage, LLC, United States
- Getting from the IND to the NDA
- NDA Data Sources and Specific Populations
- Types of NDAs
- BLAs: Biologics and Biosimilars
- Combination Products and OTC Drugs
- Patent Term Restoration and Exclusivity