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Alliance of Wound Care Stakeholders

The Alliance of Wound Care Stakeholders provided oral testimony at recent public hearings on FDA draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCTPs). Although much of the public testimony focused on issues related to stem cell therapies, the implications of these guidance documents for wound care were addressed by the Alliance, Coalition of Wound Care Manufacturers, and other stakeholder groups in attendance.


The draft FDA guidance documents may help to provide pathways forward for the development of additional innovative HCTPs and promote the safe use of these products, noted the alliance. Comments from the alliance addressed areas that needed additional clarity and alignment across guidances to make them clinically meaningful, accurate, and consistent with, rather than contradictory to, existing regulations. Of the guidance documents under discussion, the Alliance's comments focused on the "Minimal Manipulation and Homologous Use" guidances that specifically impact wound care applications. "There are many significant new requirements within the minimal manipulation document, which not only conflict with the homologous use document, but they also conflict with current regulatory language," the Alliance informed the FDA, noting a number of specific examples throughout its comments.


For full reports of comments from these proceedings, as well as other recent comments made by the Alliance to legislative bodies and regulatory agencies, visit their website.


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