{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs.\" This draft guidance is intended to clarify the recommended approach for sponsors developing drugs to treat hypertension for patients who are on a background of multiple antihypertensive drugs.","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/2018/07/16/2018-15092.html","cfr_references":[],"citation":"83 FR 32878","comment_url":null,"comments_close_on":"2018-09-14","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by September 14, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-D-2515"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":1,"comment_start_date":"2018-07-16","updated_at":"2023-03-01T03:00:55.155-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-D-2515-0001","allow_late_comments":null,"id":"FDA-2018-D-2515-0001","comment_end_date":"2018-09-15","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2018-D-2515","title":"Hypertension:  Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs; Draft Guidance for Industry; Availability"}],"document_number":"2018-15092","effective_on":null,"end_page":32880,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/07/16/2018-15092.xml","html_url":"https://www.federalregister.gov/documents/2018/07/16/2018-15092/hypertension-conducting-studies-of-drugs-to-treat-patients-on-a-background-of-multiple","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-15092?publication_date=2018-07-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-07-16/2018-15092/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":221,"last_updated":"2026-04-04 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-07-16/pdf/2018-15092.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-15092.pdf?1531485924","publication_date":"2018-07-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/07/16/2018-15092.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":1,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-D-2515","supporting_documents_count":0,"docket_id":"FDA-2018-D-2515","document_id":"FDA-2018-D-2515-0001","regulation_id_number":null,"title":"Hypertension:  Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-03-01T08:00:54Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":32878,"subtype":null,"title":"Hypertension: Conducting Studies of Drugs To Treat Patients on a Background of Multiple Antihypertensive Drugs; Draft Guidance for Industry; Availability","toc_doc":"Hypertension: Conducting Studies of Drugs to Treat Patients on Background of Multiple Antihypertensive Drugs","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}