粪便微生物群移植产品的监管考虑因素。
Regulatory Considerations for Fecal Microbiota Transplantation Products.
机构信息
Laboratory of Mucosal Pathogens and Cellular Immunology, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
出版信息
Cell Host Microbe. 2020 Feb 12;27(2):173-175. doi: 10.1016/j.chom.2020.01.018.
Fecal microbiota for transplantation (FMT) is being studied as a potential intervention for numerous conditions. The regulation of FMT by the FDA is discussed along with FMT donor screening and manufacturing considerations. The FDA is committed to ensuring that FMT products can be safely tested in clinical trials.
粪便微生物群移植（FMT）正在被研究作为许多疾病的一种潜在干预手段。本文讨论了 FDA 对 FMT 的监管，以及 FMT 供体筛选和生产方面的考虑。FDA 致力于确保 FMT 产品能够在临床试验中安全地进行测试。
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