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Review
. 2020 Feb 12;27(2):173-175.
doi: 10.1016/j.chom.2020.01.018.

Regulatory Considerations for Fecal Microbiota Transplantation Products

Paul E Carlson Jr  1
Affiliations
Free article
Review

Regulatory Considerations for Fecal Microbiota Transplantation Products

Paul E Carlson Jr. Cell Host Microbe. .
Free article

Abstract

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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