{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"M10 Bioanalytical Method Validation and Study Sample Analysis.\" The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation. The guidance describes recommendations for method validation for bioanalytical assays for nonclinical and clinical studies that generate data to support regulatory submissions, including the procedures and processes that should be characterized for chromatographic and ligand-binding assays that are used to measure the parent and active metabolites of drugs administered in nonclinical and clinical subjects. The guidance is intended to provide industry with harmonized regulatory expectations for bioanalytical method validation of assays used to support regulatory submissions. The guidance replaces the draft guidance \"M10 Bioanalytical Method Validation\" issued on June 27, 2019.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2022/11/07/2022-24113.html","cfr_references":[],"citation":"87 FR 67037","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 7, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-D-1469"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2022-11-07","updated_at":"2023-02-27T20:01:33.091-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2019-D-1469-0015","allow_late_comments":null,"id":"FDA-2019-D-1469-0015","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2019-D-1469","title":"M10 Bioanalytical Method Validation; International Council for Harmonisation; Draft Guidance for Industry; Availability"}],"document_number":"2022-24113","effective_on":null,"end_page":67039,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/11/07/2022-24113.xml","html_url":"https://www.federalregister.gov/documents/2022/11/07/2022-24113/m10-bioanalytical-method-validation-and-study-sample-analysis-international-council-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-24113?publication_date=2022-11-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-11-07/2022-24113/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":2907,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-11-07/pdf/2022-24113.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-24113.pdf?1667565918","publication_date":"2022-11-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/11/07/2022-24113.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-2019-D-1469","supporting_documents_count":0,"docket_id":"FDA-2019-D-1469","document_id":"FDA-2019-D-1469-0015","regulation_id_number":null,"title":"M10 Bioanalytical Method Validation; International Council for Harmonisation; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-02-28T01:01:32Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":67037,"subtype":null,"title":"M10 Bioanalytical Method Validation and Study Sample Analysis; International Council for Harmonisation; Guidance for Industry; Availability","toc_doc":"M10 Bioanalytical Method Validation and Study Sample Analysis; International Council for Harmonisation","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}