FDA Brief: Week of Mar 7, 2016


FDA Voice


‘Leaning in’ on Combination Products


Nina L. Hunter, Ph.D.,  Associate Director for Science Policy in the Office of Medical Products and Tobacco

Rachel E. Sherman, M.D., M.P.H., Associate Deputy Commissioner in the Office of Medical Products and Tobacco

Combination Products:

  • Combine drugs, devices, and/or biological products
  • Include components from multiple regulatory categories (e.g., drug and device, drug and biologic, biologic and device, drug, device, and biologic) with distinct regulatory requirements
  • Review requires involvement of more than one FDA Center
  • Present regulatory, policy, and review management challenges

FDA Approach:

  • Improve overall efficiency, consistency, and predictability of combination product review
  • Launch Lean Management Process Mapping

Expected Outputs:

  • Baseline Map on existing sources of delay or redundancy
  • Identify metrics for success and to assess the impact of improvements
  • Future Map  on streamlined, efficient process that will eliminate previously identified delays and redundancies
  • Reflect FDA’s prior success with Lean Management


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