FDA Issues Final Guidance on Developing Drugs for Clostridioides difficile Infection (CDI)

The Food and Drug Administration (FDA) has announced the availability of the final guidance, Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention. This guidance is designed to assist drug sponsors in the clinical development process for medications intended to treat, reduce recurrence of, or prevent Clostridioides difficile infection (CDI). The document finalizes the draft guidance that was issued on October 28, 2022.