Clostridioides Difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention; Guidance for Industry; Availability
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 This guidance finalizes the draft guidance titled "Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention" issued on October 28. 2022.
Abstract as published in the Federal Register.
The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.
View on federalregister.gov →Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.