{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Considerations for Generating Clinical Evidence From Oncology Multiregional Clinical Development Programs.\" This draft guidance provides recommendations to sponsors who are planning global clinical development programs for drugs intended to treat cancer, on improving the evidence obtained from one or more multiregional clinical trials (MRCTs) intended to support a marketing application. This draft guidance expands on principles described in FDA's existing guidance documents related to this topic, by providing additional recommendations for the planning, design, conduct, and analysis of an oncology MRCT that may facilitate FDA's assessment of applicability of the data to the U.S. population with the cancer being investigated and to U.S. medical practice.","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/2024/09/17/2024-20995.html","cfr_references":[],"citation":"89 FR 76120","comment_url":null,"comments_close_on":"2024-11-18","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by November 18, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2024-D-3163"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-09-17","updated_at":"2024-09-17T11:56:22.543-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-D-3163-0001","allow_late_comments":false,"id":"FDA-2024-D-3163-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-D-3163","title":"Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs; Draft Guidance for Industry; Availability"}],"document_number":"2024-20995","effective_on":null,"end_page":76121,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/09/17/2024-20995.xml","html_url":"https://www.federalregister.gov/documents/2024/09/17/2024-20995/considerations-for-generating-clinical-evidence-from-oncology-multiregional-clinical-development","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-20995?publication_date=2024-09-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-09-17/2024-20995/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":3754,"last_updated":"2026-09-22 10:15:08 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-17/pdf/2024-20995.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-20995.pdf?1726490717","publication_date":"2024-09-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/09/17/2024-20995.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-2024-D-3163","supporting_documents_count":0,"docket_id":"FDA-2024-D-3163","document_id":"FDA-2024-D-3163-0001","regulation_id_number":null,"title":"Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2024-09-18T14:55:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":76120,"subtype":null,"title":"Considerations for Generating Clinical Evidence From Oncology Multiregional Clinical Development Programs; Draft Guidance for Industry; Availability","toc_doc":"Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":89}