FDA's regulatory pathway "for development of probiotic drugs is reasonably clear. But the road to develop probiotic foods, supplements or microbiome-based dietary strategies to compensate for deficient microbiota is less so," says the International Scientific Association for Probiotics and Prebiotics. FDA's Center for Biologics Evaluation and Research is conducting Sept. 17 workshop to exchange information with the scientific community about the clinical, manufacturing and regulatory considerations associated with live microbiome-based products administered to treat a disease.
FDA's upcoming workshop on the biologic drug pathway for microbiome-based products' approval to treat a disease could have more impact by also discussing allowing health claims for probiotic and prebiotic dietary supplements and food products, says a research group.
FDA's Center for Biologics Evaluation and Research and the National Institute of Allergy and Infectious Diseases on Sept. 17 are...