Regulatory Considerations for Fecal Microbiota Transplantation Products

Paul E Carlson Jr

doi:10.1016/j.chom.2020.01.018

Regulatory Considerations for Fecal Microbiota Transplantation Products

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

Author

Paul E Carlson Jr¹

Affiliation

¹ 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. Electronic address: paul.carlson@fda.hhs.gov.

PMID: 32053787
DOI: 10.1016/j.chom.2020.01.018

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.

Published by Elsevier Inc.

Publication types

Review

MeSH terms

Clostridioides difficile
Clostridium Infections / prevention & control
Fecal Microbiota Transplantation* / methods
Fecal Microbiota Transplantation* / trends
Feces / microbiology*
Gastrointestinal Microbiome
Living Donors
Safety
Social Control, Formal
Treatment Outcome