GUIDANCE DOCUMENT
Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention October 2022
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
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All written comments should be identified with this document's docket number: FDA-2022-D-1261
- Docket Number:
- FDA-2022-D-1261
- Issued by:
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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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention.” The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of Clostridioides difficile infection (CDI), reduction of recurrence, or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.