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Sheraton Boston Hotel

14 ago 2017 7:30 a.m. - 17 ago 2017 5:00 p.m.

39 Dalton Street, , Boston, MA 02119 , USA

Regulatory Affairs: The IND, NDA, and Postmarketing

Session 23: Interactions with FDA - Part 2

Session Chair(s)

Elliott  Berger, PhD, MS

Elliott Berger, PhD, MS

President

ETB Regualtory Consulting, 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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