Science and Regulation of Live Microbiome-Based Products
: 17 Sep 2018
: Rockville, United States
Sector: Clinical, Food & Beverage, Pharmaceutical
The Center for Biologics Evaluation and Research (CBER), FDA is holding a public workshop 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.
For more details and registration visit: https://www.eventbrite.com/e/science-and-regulation-of-live-microbiome-based-products-used-to-prevent-treat-or-cure-diseases-in-tickets-44649072578