{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development.\" This draft guidance is intended to help sponsors planning to use circulating cell-free plasma derived tumor deoxyribonucleic acid (ctDNA) as a biomarker in cancer clinical trials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 setting.","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/2022/05/03/2022-09459.html","cfr_references":[],"citation":"87 FR 26207","comment_url":null,"comments_close_on":"2022-07-05","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by July 5, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2022-D-0084"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":13,"comment_start_date":"2022-05-03","updated_at":"2023-02-28T12:16:43.939-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-D-0084-0001","allow_late_comments":null,"id":"FDA-2022-D-0084-0001","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of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry;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":"2022-09459","effective_on":null,"end_page":26208,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/05/03/2022-09459.xml","html_url":"https://www.federalregister.gov/documents/2022/05/03/2022-09459/use-of-circulating-tumor-deoxyribonucleic-acid-for-early-stage-solid-tumor-drug-development-draft","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-09459?publication_date=2022-05-03","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-05-03/2022-09459/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":573,"last_updated":"2026-10-22 16:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-05-03/pdf/2022-09459.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-09459.pdf?1651495527","publication_date":"2022-05-03","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/05/03/2022-09459.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":13,"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-0084-0001","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":"2023-02-28T17:16:43Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":26207,"subtype":null,"title":"Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry; Availability","toc_doc":"Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}