{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment.\" The purpose of this draft guidance is to assist sponsors in clinical drug development for the treatment of adults with duodenal ulcers caused by H. pylori for the reduction of duodenal ulcer recurrence. Specifically, this guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs to support antimicrobial-containing H. pylori treatment regimens.","action":"Notice.","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/2009/10/05/E9-23875.html","cfr_references":[],"citation":"74 FR 51161","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by January 4, 2010.","disposition_notes":null,"docket_ids":["Docket No. FDA-2009-D-0447"],"dockets":[],"document_number":"E9-23875","effective_on":null,"end_page":51161,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2009/10/05/E9-23875.xml","html_url":"https://www.federalregister.gov/documents/2009/10/05/E9-23875/draft-guidance-for-industry-on-helicobacter-pylori-associated-duodenal-ulcer-disease-in-adults","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E9-23875?publication_date=2009-10-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2009-10-05/E9-23875/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":81,"last_updated":"2026-04-05 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2009-10-05/pdf/E9-23875.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2009-10-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2009/10/05/E9-23875.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":51161,"subtype":null,"title":"Draft Guidance for Industry on Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment; Availability","toc_doc":"Helicobacter pyloriAssociated Duodenal Ulcer Disease in Adults; Developing Drugs for Treatment; Availability","toc_subject":"Draft Guidance for Industry:","topics":[],"type":"Notice","volume":74}