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Guidance Issuing OfficeCenter for Drug Evaluation and Research, Office of New Drugs
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention.” The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of Clostridioides difficile infection (CDI), reduction of recurrence, or prevention of CDI.