FDA Takes Steps to Clarify Significant Human Tissue Questions

On October 30, 2015, the Food and Drug Administration (FDA) issued a draft guidance document, Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products (the Homologous Use Guidance), discussing FDA’s interpretation of homologous use and how to apply regulatory criteria for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

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