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DIA Global Center

Oct 17, 2018 8:15 AM - Oct 18, 2018 4:15 PM

21 Dupont Circle NW, Suite 300, Washington, DC 20036

Regulatory Affairs for Combination Products

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Session 9: Working with FDA: An Overview

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

Carol H. Danielson, DrPH, MS, RAC

President

Regulatory Advantage, LLC, United States

  • Meetings with lead reviewing agency
  • Managing consults and differing opinions
  • Review cycle meetings (PDUFA, special programs)

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