{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Bispecific Antibody Development Programs.\" This draft guidance provides recommendations to assist industry and other parties involved in the bispecific antibody drug development process. The draft guidance focuses on general regulatory and scientific considerations for bispecific antibodies, but not on development of a particular bispecific antibody. Industry and other stakeholders are encouraged to engage FDA to discuss their individual bispecific antibody under development.","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/2019/04/19/2019-07930.html","cfr_references":[],"citation":"84 FR 16512","comment_url":null,"comments_close_on":"2019-06-18","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by June 18, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2019-D-0621"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":13,"comment_start_date":"2019-04-19","updated_at":"2023-02-28T18:22:27.268-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2019-D-0621-0001","allow_late_comments":null,"id":"FDA-2019-D-0621-0001","comment_end_date":"2019-06-19","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2019-D-0621","title":"Bispecific Antibody Development Programs; Draft Guidance for Industry; Availability"}],"document_number":"2019-07930","effective_on":null,"end_page":16513,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/04/19/2019-07930.xml","html_url":"https://www.federalregister.gov/documents/2019/04/19/2019-07930/bispecific-antibody-development-programs-draft-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-07930?publication_date=2019-04-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-04-19/2019-07930/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1418,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-04-19/pdf/2019-07930.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-07930.pdf?1555591524","publication_date":"2019-04-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/04/19/2019-07930.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-2019-D-0621","supporting_documents_count":0,"docket_id":"FDA-2019-D-0621","document_id":"FDA-2019-D-0621-0001","regulation_id_number":null,"title":"Bispecific Antibody Development Programs; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-02-28T23:22:26Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":16512,"subtype":null,"title":"Bispecific Antibody Development Programs; Draft Guidance for Industry; Availability","toc_doc":"Bispecific Antibody Development Programs","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":84}