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Striking a cord for microbiome regulation with a path for FMTs

How FDA’s cord blood regulation could inform its control of microbiome products

As FDA considers how to exercise its regulatory authority over microbiome therapies, CBER director Peter Marks sees an opportunity to springboard off the agency’s successful model for cord blood products, which gave academic centers a streamlined path to licensing based on pooled data.

At least six late-stage trials of live intestinal microbiome therapies are poised to read out in the next 18 months (see “Mapping Microbiome Manufacturing”).

With a line of sight to approved microbiome therapies for recurrent C. difficile infection, questions about how FDA will regulate company products versus the fecal matter transplants (FMTs) available at academic centers are becoming more acute.

FDA views microbiome therapies as biologic drugs, not tissue transplants, meaning they are subject to the drug approval process. But the agency carved out a niche for FMTs in 2013 when it published a draft

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