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GUIDANCE DOCUMENT

Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention May 2026

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2022-D-1261
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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 This guidance finalizes the draft guidance titled "Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention" issued on October 28. 2022.

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-1261.

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