Microbiome Approval Pathway Workshop Could Help Sort Out Probiotic Path

Executive Summary

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.