{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Benefit- Risk Assessment for Human Drug and Biological Products.\" FDA has developed this guidance document in accordance with goals associated with the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI) under Title I of the FDA Reauthorization Act of 2017 and requirements under the 21st Century Cures Act. The intent of this guidance is to provide drug sponsors and other stakeholders with better clarity on how considerations about a drug's benefits, risks, and risk management options factor into FDA's pre- and postmarket regulatory decisions about new drug applications (NDAs) or biologics license applications (BLAs). This guidance finalizes the draft guidance of the same title issued in September 2021.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2023/10/20/2023-23161.html","cfr_references":[],"citation":"88 FR 72491","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on October 20, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-D-2316"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-10-20","updated_at":"2023-10-20T11:57:22.116-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-D-2316-0030","allow_late_comments":null,"id":"FDA-2020-D-2316-0030","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2020-D-2316","title":"Benefit-Risk Assessment for New Drug and Biological Products; Draft Guidance for Industry; Availability"}],"document_number":"2023-23161","effective_on":null,"end_page":72493,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/10/20/2023-23161.xml","html_url":"https://www.federalregister.gov/documents/2023/10/20/2023-23161/benefit-risk-assessment-for-new-drug-and-biological-products-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-23161?publication_date=2023-10-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-10-20/2023-23161/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1457,"last_updated":"2026-06-16 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-10-20/pdf/2023-23161.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-23161.pdf?1697719582","publication_date":"2023-10-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/10/20/2023-23161.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-2316","supporting_documents_count":0,"docket_id":"FDA-2020-D-2316","document_id":"FDA-2020-D-2316-0030","regulation_id_number":null,"title":"Benefit-Risk Assessment for New Drug and Biological Products; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-10-21T15:00:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":72491,"subtype":null,"title":"Benefit-Risk Assessment for New Drug and Biological Products; Guidance for Industry; Availability","toc_doc":"Benefit-Risk Assessment for New Drug and Biological Products","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}