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Westin Gaslamp Quarter, San Diego

Mar 20, 2017 7:30 AM - Mar 23, 2017 5:00 PM

910 Broadway Circle, , San Diego, CA 92101 , USA

Regulatory Affairs: The IND, NDA, and Postmarketing

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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