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Science and Regulation of Live Microbiome-Based Products Used to Prevent, Treat, or Cure Diseases in Humans
September 17, 2018 @ 9:00 am - 5:30 pm EDT
The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research and the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID) are announcing a public workshop entitled “Science and Regulation of Live Microbiome-Based Products Used to Prevent, Treat, or Cure Diseases in Humans.”
Purpose of the workshop:
The purpose of the public workshop is to exchange information with the scientific community about the clinical, manufacturing, and regulatory considerations associated with live microbiome-based products, when administered to prevent, treat, or cure a disease or condition in humans. The public workshop will bring together government agencies, academia, industry, and other stakeholders involved in research, development, and regulation of live microbiome-based products for such uses.
Live microbiome-based products used to prevent, treat, or cure a disease or condition in humans are biological products. There is increasing interest in the use of such products for the treatment and/or prevention of conditions such as necrotizing enterocolitis and diarrhea. Historically, these products have presented with unique scientific and regulatory challenges.
Topics for Discussion at the Public Workshop
The topics for discussion at the public workshop include the clinical, manufacturing, and regulatory considerations for live microbiome-based products to prevent, treat, or cure a disease or condition in humans, and the objective is to provide a forum for the exchange of information and perspectives on these topics.