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SESSION 7: INTERACTIONS WITH FDA
Session Chair(s)
Carol H. Danielson, DrPH, MS, RAC
President
Regulatory Advantage, LLC, United States
Michael Hamrell, PHD, RAC
President
MORIAH Consultants, United States
- FDA's guidance on meetings and how to request them
- Time course of events in requesting a meeting
- Objectives and conduct of specific meetings with FDA
- Principles for communicating with FDA
- Meeting etiquette
- How to resolve issues or disputes with FDA
- Summary on interacting with FDA advisory committee meetings
Speaker(s)
INTERACTIONS WITH FDA
Carol H. Danielson, DrPH, MS, RAC
Regulatory Advantage, LLC, United States
President
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