{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled \"Migraine: Developing Drugs for Acute Treatment.\" The purpose of this guidance is to assist sponsors in the clinical development of prescription drugs for the acute treatment of migraine. This guidance focuses on specific drug development and trial design issues that are unique to the study of prescription drugs for the acute treatment of migraine. This guidance finalizes the draft guidance of the same name issued October 22, 2014.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health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/2018/02/16/2018-03224.html","cfr_references":[],"citation":"83 FR 7056","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on February 16, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-1540"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2018-02-16","updated_at":"2023-06-02T14:56:30.763-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2014-D-1540-0007","allow_late_comments":null,"id":"FDA-2014-D-1540-0007","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2014-D-1540","title":"Draft Guidance for Industry on Migraine: Developing Drugs for Acute Treatment; Availability"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2022-08-15","updated_at":"2023-06-02T14:56:30.311-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-D-1729-0003","allow_late_comments":null,"id":"FDA-2022-D-1729-0003","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-D-1729","title":"Migraine: Developing Drugs for Preventive Treatment; Draft Guidance for Industry; Availability"}],"document_number":"2018-03224","effective_on":null,"end_page":7057,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/02/16/2018-03224.xml","html_url":"https://www.federalregister.gov/documents/2018/02/16/2018-03224/migraine-developing-drugs-for-acute-treatment-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-03224?publication_date=2018-02-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-02-16/2018-03224/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":387,"last_updated":"2026-08-25 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-02-16/pdf/2018-03224.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-03224.pdf?1518702350","publication_date":"2018-02-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/02/16/2018-03224.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2022-D-1729","supporting_documents_count":0,"docket_id":"FDA-2022-D-1729","document_id":"FDA-2022-D-1729-0003","regulation_id_number":null,"title":"Migraine: Developing Drugs for Preventive Treatment; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-06-03T18:00:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":7056,"subtype":null,"title":"Migraine: Developing Drugs for Acute Treatment; Guidance for Industry; Availability","toc_doc":"MigraineDeveloping Drugs for Acute Treatment","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}