Federal Register #FDA-2022-D-1261

FDA Guidance on Developing Drugs for Clostridioides Difficile Infection

This notice from the Food and Drug Administration (FDA) provides industry guidance on developing drugs for Clostridioides difficile infection (CDI). - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Center for Drug Evaluation and Research (CDER) - Purpose: - Announcement of final guidance document for industry - Guidance covers clinical development of drugs for treatment, reduction of recurrence, or prevention of CDI - Key Details: - No products, OEMs, or vendors are requested - Guidance finalizes previous draft with clarifying edits and updates - Recommendations include efficacy and nonclinical assessment considerations - Document is informational and not binding; alternative approaches are permitted if compliant with regulations - Locations: - FDA offices in Rockville and Silver Spring, Maryland - No procurement or contract opportunity is associated with this notice

Description

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry titled "Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention." This guidance aims to assist sponsors in the clinical development of drugs to support indications for treatment, reduction of recurrence, or prevention of Clostridioides difficile infection (CDI). It finalizes the draft guidance issued on October 28, 2022, with clarifying edits and updates regarding efficacy and nonclinical assessments. The guidance represents the current thinking of FDA but is not binding and allows for alternative approaches if compliant with applicable statutes and regulations.

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