CPC Comments on FDA’s “ICH Q12: Implementation Considerations for FDA-Regulated Products” Draft Guidance for Industry

On July 19, 2021, the CPC filed a comment letter regarding FDA’s “ICH Q12: Implementation Considerations for FDA-Regulated Products” Draft Guidance. The CPC appreciates FDA’s efforts to incorporate many of the CPC’s suggestions regarding the application of ICH Q12 to combination products into FDA’s Draft Guidance. Further, CPC believes that the Draft Guidance represents a significant step forward toward enabling the combination product industry to implement ICH Q12 tools.  The comments also seek additional clarity regarding the term “indirect contact” as used in the Draft Guidance.