Comments to FDA draft guidance “Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products”

The Coalition submitted comments to the FDA on their draft guidance on the Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products, FDA-2015-D-3581, stating that despite a few concerns with the clarity of the FDA guidance document, the Coalition supports the FDA’s choices of terminology revolving around human cell and tissue products (HCT-Ps). The Coalition outlines concerns, however, with the FDA’s draft guidance on homologous uses for amnion tissue and the FDAs perception of “manufacturer objective intent.” The Coalition also addresses evidentiary and clarification concerns throughout the regulation.  
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