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SESSION 4: HOW TO SUBMIT A NDA AND ACTION ON APPLICATIONS
Session Chair(s)
Carol H. Danielson, DrPH, MS, RAC
President
Regulatory Advantage, LLC, United States
Michael Hamrell, PHD, RAC
President
MORIAH Consultants, United States
- How to submit a new drug application
- Electronic submissions
- Processing an NDA
- Amendments to an unapproved application
- FDA actions on applications
- Benchmarks: Prescription Drug User Fee Act (PDUFA) metrics
Speaker(s)
HOW TO SUBMIT A NDA AND ACTION ON APPLICATIONS
Carol H. Danielson, DrPH, MS, RAC
Regulatory Advantage, LLC, United States
President
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