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U.S. Department of Health and Human Services

Scientific Publications by FDA Staff

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Cell Host Microbe 2020 Feb 12;27(2):173-5

Regulatory considerations for fecal microbiota transplantation products.

Carlson PE Jr


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.

Category: Journal Article, Editorial
PubMed ID: #32053787 DOI: 10.1016/j.chom.2020.01.018
Includes FDA Authors from Scientific Area(s): Biologics
Entry Created: 2019-12-01 Entry Last Modified: 2020-03-08