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2013 Archived Content

(SC18) Regulatory Approval of a Therapeutic & Companion Diagnostic: Nuts & Bolts  

Overview of the requirements and processes for coordinated NDA/PMA or BLA/PMA submissions leading to simultaneous approvals of a therapeutic and companion diagnostic; from working with CDER, CBER and CDRH to labeling considerations, as well as an overview of the evolving Rx/Dx regulatory landscape.
Nancy Gerber, Associate Director, Regulatory Affairs, Genentech
Erling Thor Donnelly, Ph.D., R.A.C., Director, Worldwide Regulatory Strategy, Pfizer, Inc.
Pamela L. Swatkowski, Director, Regulatory Affairs, Abbott Molecular, Inc.

This course will cover:

  • Overview of US requirements and processes  
  • US government oversight of diagnostics
  • Diagnostic clearance and approval pathways
  • Predictive and prognostic diagnostics
  • Co-development process & timelines
  • Regulatory challenges   
  • FDA guidances and environment
  • Integration of Rx and Dx development plans
  • Navigating the development process
  • Co-development examples and lessons learned  
  • Historical examples (Erbitux, Vectibix)
  • Recent Scenarios (Xalkori, Zelboraf)
  • Approval path for devices ex-US
  • EU, Canada and Japan considerations

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