{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization.\" This guidance provides recommendations to sponsors on the development of monoclonal antibody products targeting SARS-CoV-2 intended for the prevention or treatment of COVID- 19, including addressing the impact of emerging variants. The recommendations focus on the data and information that may be used to support a request for emergency use authorization (EUA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance supersedes the guidance entitled \"Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency\" issued on February 22, 2021.","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/2023/12/21/2023-28092.html","cfr_references":[],"citation":"88 FR 88401","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on December 21, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-D-1136"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2023-12-21T11:56:48.572-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-D-1136-0084","allow_late_comments":null,"id":"FDA-2020-D-1136-0084","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2020-D-1136","title":"Center for Drug Evaluation and Research (CDER):  COVID-19"}],"document_number":"2023-28092","effective_on":null,"end_page":88402,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/12/21/2023-28092.xml","html_url":"https://www.federalregister.gov/documents/2023/12/21/2023-28092/development-of-monoclonal-antibody-products-targeting-sars-cov-2-for-emergency-use-authorization","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-28092?publication_date=2023-12-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-12-21/2023-28092/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":395,"last_updated":"2026-09-20 18:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-12-21/pdf/2023-28092.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-28092.pdf?1703079934","publication_date":"2023-12-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/12/21/2023-28092.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-2020-D-1136","supporting_documents_count":0,"docket_id":"FDA-2020-D-1136","document_id":"FDA-2020-D-1136-0084","regulation_id_number":null,"title":"Center for Drug Evaluation and Research (CDER):  COVID-19","checked_regulationsdotgov_at":"2023-12-22T16:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":88401,"subtype":null,"title":"Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization; Guidance for Industry; Availability","toc_doc":"Development of Monoclonal Antibody Products Targeting SARSCoV2 for Emergency Use Authorization","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}