By Joy Curzio
Scientific data about the efficacy and safety of fecal microbiota transplantation (FMT) for adult and pediatric patients with recurring or resistant Clostridioides difficile were among the topics covered at the FDA’s public hearing on the topic.
The FDA is trying to balance the scientific development and approval of a commercial product and open-label access, via stool banks, for patients who need a treatment immediately—before a commercial product is available.