CPC Submits Comments on FDA’s Premarket Pathways Draft Guidance

On May 6, 2019, CPC provided comments on FDA’s “Principles of Premarket Pathways for Combination Products: Draft Guidance for Industry and FDA Staff.” Although the document helps clarify certain FDA expectations, among other feedback, the CPC recommends that FDA: (i) include additional guidance on considerations for cross-labeled combination products with respect to the one v. multiple application determination; (ii) provide additional guidance on when the data and information needed to obtain marketing authorization for a non-lead constituent part either differs or does not differ from that needed as a stand-alone product; and (iii) provide further guidance on how to effectively utilize prior FDA findings of safety or effectiveness or substantial equivalence of an approved or cleared constituent part.