September 27, 2016
The Alliance submitted comments to the FDA on its "Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products - draft guidances for industry and FDA staff." The Alliance highlighted a number of issues with regard to "main function" and "basic function" terminology in the guidance. Comments also identified multiple inconsistencies between the "Minimal Manipulation" guidance and the "Homologous Use" guidance. The Alliance encouraged the FDA should work with stakeholders to develop an appropriate guidance document that is consistent with guidances and current regulatory language and that provides needed clarity.
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