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University of Southern California

Mar 13, 2016 7:30 AM - Mar 16, 2016 5:00 PM

Center for the Health Professionals, 1540 Alcazar Street #140, Los Angeles, CA 90089

Regulatory Affairs: The IND, NDA, and Postmarketing

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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