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  1. The FDA Science Forum

2021 FDA Science Forum

One Health Microbiome Research Across FDA Centers

Poster Author(s)
Silvia Pineiro FDA/CVM; Andrea Ottesen FDA/CVM; Daniel Tadesse FDA/CVM; Jennifer Brzezinski FDA/ORA; Paul Morin FDA/ORA; Paul Carlson FDA/CBER; Siobhan Cowley FDA/CBER; Kathleen Clouse FDA/CDER; Odile Engel FDA/CDER; Joseph Briggs FDA/DCRH; Alyxandria Schubert FDA/CDRH; David CraftFDA/CTP; Aimee Cunningham FDA/CTP; Jennifer Patro FDA/CTP; Bruce Erickson FDA/NCTR; Sangeeta Khare FDA/NCTR; Khaled Bouri FDA/OCS; Shari Solomon FDA/OCS; Lauren Viebrock FDA/CFSAN; Jayanthi Gangiredla FDA/CFSAN; Carmen Tartera FDA/CFSAN
Contributing Office
Center for Veterinary Medicine


Poster Abstract

In response to the rapid advancement of science and technology and corresponding implications for FDA-regulated products, FDA Regulatory Science Strategic priorities now include microbiome research sciences. The term microbiome refers to the community of microbial species connected by physical location, interrelationships of function, and collective genomic potential. There is extensive data-based evidence that human, animal and environmental microbiota play highly significant and varied roles in states of health and disease. As FDA regulates a broad range of products and devices that interact either directly or indirectly with human and animal microbiota, multiple Centers and Offices are involved in research that spans microbiology, toxicology, nutrition, immunology, antimicrobial resistance and a wide range of additional categories. Food, antibiotics, drug and chemical residues may shape gastrointestinal microbiota, cosmetics may alter skin microbiota, and metabolites of all of these may influence complex microbiome mediated processes highly significant to human health. Additionally, FDA regulates and evaluates products that are comprised intentionally or unintentionally of microbes and/or microbial communities such as fecal microbiota transplants, live microbes in foods, dietary supplements, tobacco products, and live biotherapeutic products. Microbiome research provides insight into the mechanistic action of such products to lead to data based evaluation of potential toxic or beneficial effects and correlated recommendations and regulatory policy. Here, representatives of the Microbiome Working Group (MWG) (which spans 9 Centers and Offices) provide a comprehensive portfolio of FDA microbiome research in their respective Centers and Offices, as well as, a snapshot of intra and interagency collaborative efforts. Details of some of these research components will be highlighted here and additionally presented as individual posters.

Poster Image
Preview image of the scientific poster. For more information, please refer to the abstract or download the PDF version of the poster.

Download the Poster (PDF; 0.67 MB)

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