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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 23: Interactions with FDA - Part 2

Session Chair(s)

Michael Hamrell, PhD, RAC

Michael Hamrell, PhD, RAC

President

MORIAH Consultants, United States

  • Principles for Communicating with FDA
  • Meeting Etiquette
  • Resolving Issues or Disputes with FDA
  • Summary on Interacting with FDA
  • Advisory Committee Meetings
  • Advisory Committee Meeting Video

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