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This session was jointly developed by AGA and representatives from the Division of Gastroenterology at the FDA Center for Drug Evaluation and Research. This session will give health care professionals and clinical trialists a chance to hear directly from FDA representatives about the agency's thinking behind the most recent product approvals and guidance documents impacting the GI community. The 2023 session will address new therapies for IBD, EoE, and C. difficile infection, as well as the agency's current thinking on artificial intelligence-enabled medical devices.
Through the history of gut microbiome research, basic, translational, and clinical studies revealed many critical roles played by gut-resident bacteria in affecting human health and disease…
The role of nutrition and the microbiome is evident in IBD and functional bowel disorders. The microbiome can affect the way nutrients are metabolized in bioactive components. It is of important to understand the molecular sensors of such metabolized components…
This session highlights thecurrent FDA approved microbiome therapeutics and their applications and the exciting avenues being pursued for the next generation of microbiome therapeutics using gene editing and synthetic microbial communities…
Perturbations in the gut mucosal immune response contributes to IBD. Non-immune cell popopulations including epithelial and stromal cells also play an important role in intestinal inflammation…