{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Multiple Endpoints in Clinical Trials.\" This guidance provides sponsors and review staff with the Agency's thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in clinical trials for human drugs, including drugs subject to licensing as biological products. This guidance finalizes the draft guidance of the same title issued on January 13, 2017.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2022/10/21/2022-22882.html","cfr_references":[],"citation":"87 FR 64055","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on October 21, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA 2016-D-4460"],"dockets":[{"supporting_documents":[{"title":"Multiple Endpoints in Clinical Trials Guidance for Industry","document_id":"FDA-2016-D-4460-0024"},{"title":"Multiple Endpoints in Clinical Trials; Guidance for Industry; Availability","document_id":"FDA-2016-D-4460-0023"},{"title":"Draft Guidance for Multiple Endpoints in Clinical Trials","document_id":"FDA-2016-D-4460-0002"},{"title":"Multiple Endpoints in Clinical Trials; Draft Guidance for Industry; Availability","document_id":"FDA-2016-D-4460-0001"}],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2022-10-21","updated_at":"2023-02-27T13:18:58.559-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2016-D-4460-0023","allow_late_comments":null,"id":"FDA-2016-D-4460-0023","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":4,"id":"FDA-2016-D-4460","title":"Multiple Endpoints in Clinical Trials; Draft Guidance for Industry; Availability "}],"document_number":"2022-22882","effective_on":null,"end_page":64057,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/10/21/2022-22882.xml","html_url":"https://www.federalregister.gov/documents/2022/10/21/2022-22882/multiple-endpoints-in-clinical-trials-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-22882?publication_date=2022-10-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-10-21/2022-22882/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":641,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-10-21/pdf/2022-22882.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-22882.pdf?1666269928","publication_date":"2022-10-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/10/21/2022-22882.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Multiple Endpoints in Clinical Trials Guidance for Industry","document_id":"FDA-2016-D-4460-0024"},{"title":"Multiple Endpoints in Clinical Trials; Guidance for Industry; Availability","document_id":"FDA-2016-D-4460-0023"},{"title":"Draft Guidance for Multiple Endpoints in Clinical Trials","document_id":"FDA-2016-D-4460-0002"},{"title":"Multiple Endpoints in Clinical Trials; Draft Guidance for Industry; Availability","document_id":"FDA-2016-D-4460-0001"}],"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-2016-D-4460","supporting_documents_count":4,"docket_id":"FDA-2016-D-4460","document_id":"FDA-2016-D-4460-0023","regulation_id_number":null,"title":"Multiple Endpoints in Clinical Trials; Draft Guidance for Industry; Availability ","checked_regulationsdotgov_at":"2023-02-27T18:18:57Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":64055,"subtype":null,"title":"Multiple Endpoints in Clinical Trials; Guidance for Industry; Availability","toc_doc":"Multiple Endpoints in Clinical Trials","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}