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Session 22: Interactions with FDA - Part 1
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
- FDA’s Guidance on Meetings
- Time Course of Events in Requesting and Preparing for a Meeting
- Objectives and Conduct of Specific Meetings with FDA
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