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Live Biotherapeutic Products: U.S. Regulatory Evolution, Trends, and Lessons

Introduction Live biotherapeutic products (LBPs) have progressed from experimental fecal microbiota transplantation to FDA-approved biological products, while development efforts increasingly include defined microbial consortia and genetically modified strains. The approvals of Rebyota in 2022 and Vowst in 2023 showed that living microbial products can meet U.S. standards for safety, purity, potency, and effectiveness. However, these [...]