A decade of advances in human gut microbiome-derived biotherapeutics

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Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies (US Food and Drug Administration, 2022); https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances

Faecal Microbiota Transplant Products Regulation (Therapeutic Goods Administration, 2023); https://www.tga.gov.au/products/biologicals-blood-and-tissues-and-advanced-therapies/biologicals/faecal-microbiota-transplant-products-regulation

Faecal Microbiota Transplantation: EU-IN Horizon Scanning Report (European Medicines Agency & Heads of Medicines Agencies, 2022); https://www.pharmabiotic.org/eu-innovation-network-ema-horizon-scanning-report-fmt/

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