FDA-2025-P-3129

Requests that the FDA Rescind or Revise the 2022 FMT Enforcement Discretion Guidance for recurrent C. diff. infections; End Indefinite IND Commercial Usage and Impose Clinical Holds Where Appropriate; Impose Clinical Holds on, or Terminate, Non-Progressing INDs; Prohibit Commercial Distribution of FMT Under IND and Audit IND Sponsors; Enforce IND Sponsor Obligations for FMT Studies