Microbiome Approval Pathway Workshop Could Help Sort Out Probiotic Path
This article was originally published in The Rose Sheet
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.
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While stockpiling for immune health support drove early sales growth in response to the pandemic, probiotic sales likely will continue increasing, says DuPont Nutrition probiotic marketing head Vanessa Bailey. “My gut tells me I think we could see some sustained increase. There’s going to be some difference in how we behave.”
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