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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

Session 2: Combination Products by Type

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

Carol H. Danielson, DrPH, MS, RAC

President

Regulatory Advantage, LLC, United States

  • Single entity combinations
  • Co-packaged combinations
  • Co-labeled combinations
  • Not combinations under 21 CFR 3.23.2
    • Companion diagnostics
    • Fixed dose combinations

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