Striking a cord for microbiome regulation with a path for FMTs

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”). ...