USA - FDA drafts two guidances on safety testing for cell and gene therapy products

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Tuesday issued two draft guidances related to cell and gene therapy testing: one addresses safety testing products derived of human allogeneic cells expanded for use in cell-based products and the other addresses testing animal- and human-derived materials in the manufacturing of cell and gene therapy and tissue engineered medical products (TEMP). More information on the Regulatory Focus Website.