Clostridioides difficile Infection

Docket Number: FDA-2022-D-1261 Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research, Office of New Drugs

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 This guidance finalizes the draft guidance titled “Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention” issued on October 28. 2022.

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

• Content current as of:

  05/08/2026

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