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Sheraton Philadelphia University City

Oct 23, 2017 7:30 AM - Oct 26, 2017 5:00 PM

3549 Chestnut Street, Philadelphia, PA 19104

Regulatory Affairs: The IND, NDA, and Postmarketing

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Session 22: Interactions with FDA - Part 1

Session Chair(s)

Michael Hamrell, PhD, RAC

Michael Hamrell, PhD, RAC

President

MORIAH Consultants, 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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