Unique Considerations in the Approval of Combination Products and Companion Diagnostics

July 28, 2017 8:45am

Nancy Stade
Sidley Austin LLP (Washington, DC)

  • Companion diagnostics
    • The regulation of laboratory developed tests (LTDs)
    • In vitro diagnostic devices (IVDs) and Next
    • Generation Sequencing (NGS) IVDs
  • Combination Products
    • What are the requirements for approval of combination products?
    • What is the regulatory pathway?
    • Request for designation process (RFD) and the newly-created pre-RFD process
    • Role of the Combination Product Policy Council