A set of stringent new requirements from the FDA for investigating fecal transplantation raise new—and old—questions about the future of the procedure. Experts say the rules could push the field away from stool donation and toward lab-grown combinations of organisms, perhaps under the aegis of industry, or it could drive more patients to try the treatment on themselves.
In a June 13 safety alert, the agency announced that two serious infections, one fatal, had occurred due to