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CPC Companion Diagnostic Questions Final

The Combination Products Coalition Personalized Medicine Working Group’s outline of key issues and questions regarding FDA’s Draft Companion Diagnostics Guidance that framed the discussions during the June 21, 2012 meeting with FDA.

Questions concern:

  • FDA’s thinking on the distinctions between companion diagnostics and combination products.
  • The use of de novo petitions with companion diagnostics.
  • The evidence required supporting approval of companion diagnostics, with a focus on cases where companion diagnostics are not developed contemporaneously with therapeutics.
  • Labeling associated with companion diagnostics.
  • The timing of therapeutic and companion diagnostic approvals.
  • General issues regarding the regulatory process.