FDA hears testimony on enforcement discretion of FMT for C. diff

The FDA held a public comment session on Monday in Washington, D.C., to hear testimony on the agency’s policy on enforcement discretion of fecal microbiota transplantation for patients with recurrent Clostridioides difficile infection, as well as what is needed to make a path forward toward approval.Manufacturers, researchers, clinicians and patients were on hand to discuss how the policy has impacted everything from enrollment in clinical trials to the actual management of sick patients.While FMT has not been approved for the treatment of any disease, over the last few years, the FDARead More

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