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The Westin Boston Waterfront

Aug 13, 2018 7:45 AM - Aug 16, 2018 5:00 PM

425 Summer Street, Boston, MA 02210

Regulatory Affairs: The IND, NDA, and Post-Marketing

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Session 22: 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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