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The Westin Boston Waterfront

Aug 15, 2016 7:30 AM - Aug 18, 2016 5:00 PM

425 Summer Street, Boston, MA 02210

Regulatory Affairs: The IND, NDA, and Postmarketing

Session 23: Interactions with FDA - Part 2

Session Chair(s)

Drusilla  Scott, PhD, RAC

Drusilla Scott, PhD, RAC

Vice President, Regulatory Affairs

Sobi, Inc., United States

Carol H. Danielson, DrPH, MS, RAC

Carol H. Danielson, DrPH, MS, RAC

President

Regulatory Advantage, LLC, 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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