{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Hypertension: Developing Fixed-Combination Drug Products for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of fixed-combination drug products for the treatment of hypertension. The guidance focuses on development of two- drug combinations of previously approved drug products. This guidance incorporates the comments received for and finalizes the draft guidance for industry entitled ``Hypertension: Developing Fixed-Dose Combination Drugs for Treatment'' issued on January 26, 2018.","action":"Notice of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/2018/11/07/2018-24315.html","cfr_references":[],"citation":"83 FR 55728","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on November 7, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-D-3860"],"dockets":[],"document_number":"2018-24315","effective_on":null,"end_page":55729,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/11/07/2018-24315.xml","html_url":"https://www.federalregister.gov/documents/2018/11/07/2018-24315/hypertension-developing-fixed-combination-drug-products-for-treatment-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-24315?publication_date=2018-11-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-11-07/2018-24315/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":276,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-11-07/pdf/2018-24315.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-24315.pdf?1541511933","publication_date":"2018-11-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/11/07/2018-24315.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-D-3860","supporting_documents_count":0,"docket_id":"FDA-2018-D-3860","regulation_id_number":null,"title":"Hypertension:  Developing Fixed-Combination Drug Products for Treatment; Guidance for Industry; Availability ","checked_regulationsdotgov_at":"2018-11-27T11:00:26Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":55728,"subtype":null,"title":"Hypertension: Developing Fixed-Combination Drug Products for Treatment; Guidance for Industry; Availability","toc_doc":"Hypertension: Developing Fixed-Combination Drug Products for Treatment","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}