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CPC Files Comments on FDA’s Draft Bridging Guidance

On February 14, 2020, CPC filed comments on FDA’s “Bridging for Drug-Device and Biologic-Device Combination Products Guidance for Industry” (which was issued on December 18, 2019). CPC believes the development of a step-wise process approach and framework to conduct a gap analysis and for identifying (and closing) these information gaps is a valuable element of the Draft Guidance, and is consistent with and builds upon key ICH guidance documents (Q5e comparability, Q9 QRM) on comparability analysis and risk assessments. CPC further appreciates the ample references and broad allowances for leveraging prior experience throughout the Draft Guidance, demonstrating the willingness of FDA to consider prior knowledge of drug attributes and device platforms. Unfortunately, CPC found the format FDA chose to use in the Draft Guidance to convey study recommendations to be confusing and limiting in the ability to provide useful guidance on the needed bridging information.