{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.\" For drugs granted accelerated approval, sponsors conduct confirmatory studies that must be completed postapproval to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. This draft guidance describes FDA's interpretation of the term \"underway\" and discusses policies for implementing this requirement, including factors FDA intends to consider when determining whether a confirmatory trial is underway prior to accelerated approval.","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/2025/01/07/2024-31527.html","cfr_references":[],"citation":"90 FR 1171","comment_url":null,"comments_close_on":"2025-03-10","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by March 10, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Submit electronic or written comments on the proposed collection of information in the draft guidance by March 10, 2025.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-D-3334"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2025-01-07T12:56:40.895-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-D-3334-0001","allow_late_comments":false,"id":"FDA-2024-D-3334-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-D-3334","title":"Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway; Draft Guidance for Industry; Availability"}],"document_number":"2024-31527","effective_on":null,"end_page":1173,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/01/07/2024-31527.xml","html_url":"https://www.federalregister.gov/documents/2025/01/07/2024-31527/accelerated-approval-and-considerations-for-determining-whether-a-confirmatory-trial-is-underway","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-31527?publication_date=2025-01-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-01-07/2024-31527/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1029,"last_updated":"2026-09-22 06:15:08 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31527.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31527.pdf?1736171120","publication_date":"2025-01-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/01/07/2024-31527.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-3334","supporting_documents_count":0,"docket_id":"FDA-2024-D-3334","document_id":"FDA-2024-D-3334-0001","regulation_id_number":null,"title":"Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2025-01-08T17:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":1171,"subtype":null,"title":"Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway; Draft Guidance for Industry; Availability","toc_doc":"Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}