{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Clinical Pharmacology Considerations for Antibody-Drug Conjugates,\" which provides recommendations for the development of antibody-drug conjugates (ADCs). Specifically, this guidance addresses the FDA's current thinking regarding clinical pharmacology considerations and recommendations for ADC development programs, including bioanalytical methods, dose selection and adjustment, dose- and exposure-response analysis, intrinsic factors, QTc assessments, immunogenicity, and drug- drug interactions (DDIs) for ADCs with a cytotoxic small-molecule drug or payload. Currently, there are no final FDA guidances outlining the clinical pharmacology considerations for ADCs. This guidance finalizes the draft guidance of the same title issued on February 8, 2022.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2024/03/01/2024-04375.html","cfr_references":[],"citation":"89 FR 15208","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on March 1, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-D-1051"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-03-01","updated_at":"2024-03-01T11:59:36.913-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-D-1051-0014","allow_late_comments":null,"id":"FDA-2021-D-1051-0014","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2021-D-1051","title":"Clinical Pharmacology Considerations for Antibody-Drug Conjugates; Draft Guidance for Industry; Availability"}],"document_number":"2024-04375","effective_on":null,"end_page":15210,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/03/01/2024-04375.xml","html_url":"https://www.federalregister.gov/documents/2024/03/01/2024-04375/clinical-pharmacology-considerations-for-antibody-drug-conjugates-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-04375?publication_date=2024-03-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-03-01/2024-04375/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":474,"last_updated":"2026-04-04 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-03-01/pdf/2024-04375.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-04375.pdf?1709214330","publication_date":"2024-03-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/03/01/2024-04375.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-2021-D-1051","supporting_documents_count":0,"docket_id":"FDA-2021-D-1051","document_id":"FDA-2021-D-1051-0014","regulation_id_number":null,"title":"Clinical Pharmacology Considerations for Antibody-Drug Conjugates; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2024-03-02T15:00:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":15208,"subtype":null,"title":"Clinical Pharmacology Considerations for Antibody-Drug Conjugates; Guidance for Industry; Availability","toc_doc":"Clinical Pharmacology Considerations for Antibody-Drug Conjugates","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":89}