FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: CLOSTRIDIOIDES DIFFICILE INFECTION: DEVELOPING DRUGS FOR TREATMENT, REDUCTION OF RECURRENCE, OR PREVENTION; GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, May 11 -- Food and Drug Administration has issued a notice called: Clostridioides Difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention; Guidance for Industry; Availability.

The notice was published in the Federal Register on May 11 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled " Clostridioides difficileInfection: 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, reducti...