{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development.\" This guidance is intended to help sponsors planning to use circulating cell-free plasma derived tumor DNA (ctDNA) as a biomarker in cancer clinical trials conducted under an investigational new drug application (IND) and/or to support marketing approval of drugs and biological products for treating solid tumor malignancies in the early-stage (curative-intent) setting. This guidance finalizes the draft guidance entitled \"Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development\" issued on May 2, 2022.","action":"Notice of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/2024/11/29/2024-28033.html","cfr_references":[],"citation":"89 FR 94738","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on November 29, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-D-0084"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-11-29","updated_at":"2024-11-29T11:01:28.036-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-D-0084-0021","allow_late_comments":false,"id":"FDA-2022-D-0084-0021","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-D-0084","title":"Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry; Availability"}],"document_number":"2024-28033","effective_on":null,"end_page":94740,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/11/29/2024-28033.xml","html_url":"https://www.federalregister.gov/documents/2024/11/29/2024-28033/use-of-circulating-tumor-deoxyribonucleic-acid-for-curative-intent-solid-tumor-drug-development","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-28033?publication_date=2024-11-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-11-29/2024-28033/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":514,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-11-29/pdf/2024-28033.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-28033.pdf?1732715149","publication_date":"2024-11-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/11/29/2024-28033.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-0084","supporting_documents_count":0,"docket_id":"FDA-2022-D-0084","document_id":"FDA-2022-D-0084-0021","regulation_id_number":null,"title":"Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2024-11-30T15:00:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":94738,"subtype":null,"title":"Use of Circulating Tumor Deoxyribonucleic Acid for Curative-Intent Solid Tumor Drug Development; Guidance for Industry; Availability","toc_doc":"Use of Circulating Tumor Deoxyribonucleic Acid for Curative-Intent Solid Tumor Drug Development","toc_subject":"Guidance","topics":[],"type":"Notice","volume":89}