Issue Date: May 8, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Antimicrobial
Status: Final
Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled “Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention.” The purpose of this guidance is to assist sponsors in the clinical development of drugs to support an indication of treatment, reduction of recurrence, or prevention of Clostridioides difficile infection (CDI). This guidance finalizes the draft guidance titled “Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention” issued on October 28. 2022.
Download the Guidance Document
