Regulatory Considerations for Fecal Microbiota Transplantation Products
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 c...
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| Veröffentlicht in: | Cell host & microbe 2020-02, Vol.27 (2), p.173-175 |
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| Format: | Artikel |
| Sprache: | eng |
| Online-Zugang: | Volltext |
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| Zusammenfassung: | 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. |
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| ISSN: | 1931-3128 1934-6069 |
| DOI: | 10.1016/j.chom.2020.01.018 |