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).
When finalized, these documents will supplement two final guidances, Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs), which was released in January 2020, and the 2008 guidance Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs). (RELATED: FDA Finalizes 6 Gene Therapy Guidances, Unveils a New Draft, Regulatory Focus 28 January 2020)…
