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Regulatory Considerations for Fecal Microbiota Transplantation Products.
Cell Host & Microbe ( IF 30.3 ) Pub Date : 2020-02-12 , DOI: 10.1016/j.chom.2020.01.018
Paul E Carlson 1
Affiliation  

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.

中文翻译:

粪便微生物移植产品的监管注意事项。

粪便微生物移植(FMT)正在研究中,作为对许多疾病的潜在干预措施。讨论了FDA对FMT的规定以及FMT供体筛选和制造注意事项。FDA致力于确保FMT产品可以在临床试验中安全地进行测试。
更新日期:2020-02-20
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