{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products.\" This guidance provides considerations for sponsors proposing to design a registry or to use an existing registry to support regulatory decision-making about a drug's effectiveness or safety. FDA is issuing this guidance as part of its Real-World Evidence (RWE) Program and to satisfy, in part, the mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue guidance on the use of RWE in regulatory decision-making. This guidance finalizes the draft guidance of the same title issued on November 30, 2021.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2023/12/22/2023-28289.html","cfr_references":[],"citation":"88 FR 88631","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 22, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-D-1146"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2023-12-22T10:56:38.439-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-D-1146-0042","allow_late_comments":null,"id":"FDA-2021-D-1146-0042","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2021-D-1146","title":"Real-World Data:  Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability"}],"document_number":"2023-28289","effective_on":null,"end_page":88633,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/12/22/2023-28289.xml","html_url":"https://www.federalregister.gov/documents/2023/12/22/2023-28289/real-world-data-assessing-registries-to-support-regulatory-decision-making-for-drug-and-biological","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-28289?publication_date=2023-12-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-12-22/2023-28289/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1512,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-12-22/pdf/2023-28289.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-28289.pdf?1703166338","publication_date":"2023-12-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/12/22/2023-28289.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-2021-D-1146","supporting_documents_count":0,"docket_id":"FDA-2021-D-1146","document_id":"FDA-2021-D-1146-0042","regulation_id_number":null,"title":"Real-World Data:  Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-12-23T15:00:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":88631,"subtype":null,"title":"Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry; Availability","toc_doc":"Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}