In a newly finalized guidance, the US Food and Drug Administration (FDA) laid out its criteria for applying enforcement discretion for new fecal microbiota treatments (FMT) being developed in investigational new drug applications (INDs) for Clostridioides difficile infections (CDI) in patients who do not respond to standard therapies.
The final guidance reaffirms the draft version in affirming that regulatory discretion will not apply to FMTs obtained from stool banks.
FDA said that “in development of this policy FDA has considered input from stakeholders, including physicians, scientists, and patients concerned about sufficient access to FMT for patients with C. difficile infection not responding to standard therapies. FDA has developed this policy to help facilitate access for such patients, while addressing and controlling the risks that centralized manufacturing in stool banks presents to individuals receiving such products.”…
