{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Bispecific Antibody Development Programs.\" This guidance provides recommendations to assist industry and other parties involved in the development of bispecific antibodies. The guidance focuses on general regulatory and scientific considerations for bispecific antibodies, but not on development of a particular bispecific antibody. This guidance finalizes the draft guidance of the same title issued on April 19, 2019.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2021/05/25/2021-11026.html","cfr_references":[],"citation":"86 FR 28115","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on May 25, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-D-0621"],"dockets":[],"document_number":"2021-11026","effective_on":null,"end_page":28116,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/05/25/2021-11026.xml","html_url":"https://www.federalregister.gov/documents/2021/05/25/2021-11026/bispecific-antibody-development-programs-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-11026?publication_date=2021-05-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-05-25/2021-11026/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":885,"last_updated":"2026-04-04 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-05-25/pdf/2021-11026.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-11026.pdf?1621860345","publication_date":"2021-05-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/05/25/2021-11026.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-0621","supporting_documents_count":0,"docket_id":"FDA-2019-D-0621","document_id":"FDA-2019-D-0621-0018","regulation_id_number":null,"title":"Bispecific Antibody Development Programs; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2021-05-26T03:30:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":28115,"subtype":null,"title":"Bispecific Antibody Development Programs; Guidance for Industry; Availability","toc_doc":"Bispecific Antibody Development Programs","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":86}