The Coalition provided oral testimony at the FDA's Public Hearing on Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (CTPs), acknowledging many FDA recommendations that the Coalition agrees with regarding minimal manipulation and homologous use. However, the Coalition also outlined issues with the process the FDA uses in issuing guidance documents. This process, argues the Collation, would benefit from significantly increased stakeholder input. Furthermore, the Coalition recommends that the FDA go through an appropriate regulatory process when they wish to make substantive changes within a given guidance document.
view coalition testimony
September 1, 2016