{"abstract":"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 This guidance finalizes the draft guidance titled \"Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention\" issued on October 28.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.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2026/05/11/2026-09267.html","cfr_references":[],"citation":"91 FR 25578","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on May 11, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-D-1261"],"dockets":[],"document_number":"2026-09267","effective_on":null,"end_page":25579,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/05/11/2026-09267.xml","html_url":"https://www.federalregister.gov/documents/2026/05/11/2026-09267/clostridioides-difficile-infection-developing-drugs-for-treatment-reduction-of-recurrence-or","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-09267?publication_date=2026-05-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-05-11/2026-09267/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":217,"last_updated":"2026-09-22 16:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-11/pdf/2026-09267.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-09267.pdf?1778244315","publication_date":"2026-05-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/05/11/2026-09267.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2026-05-09T05:19:37Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":25578,"subtype":null,"title":"Clostridioides Difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention; Guidance for Industry; Availability","toc_doc":"Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}