Microbiome drugs will likely be classified biologics

Under which approval pathway will microbiome-based therapeutics eventually fall? These little gut bugs are increasingly showing medical promise, and there's been rampant debate over whether they'll be treated more as medicines, or as transplantable tissues akin to harvested kidneys or hearts. Might the imminent departure of FDA Commissioner Scott Gottlieb, and the arrival of a successor, scramble the debate over the microbiome's designation?

Industry leaders aren't so concerned, STAT's Kate Sheriden reports. They're widely assuming these treatments will be seen as biologic drugs, and follow that regulatory pathway.

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