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Session 15: The NDA in CTD Format: Types of NDAs
Session Chair(s)
Drusilla Scott, PhD, RAC
Vice President, Regulatory Affairs
Sobi, Inc., United States
Carol H. Danielson, DrPH, MS, RAC
President
Regulatory Advantage, LLC, United States
- Getting from the IND to the NDA
- Considerations in Planning for the NDA
- Study Data from Different Populations
- Types of NDAs
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