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Session 17: The NDA in CTD Format: How to Submit and Action on Applications
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
- Electronic Submissions
- Processing an NDA
- Amendments to an Unapproved Application
- FDA Review of Applications and Actions on Applications
- PDUFA