{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.\" FDA is issuing this guidance as part of its Real-World Evidence (RWE) Program for drugs and to satisfy, in part, the mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue guidance about the use of RWE in regulatory decision making. This guidance discusses the applicability of FDA's investigational new drug application (IND) regulations to various clinical study designs that utilize real-world data (RWD) and clarifies the Agency's expectations regarding clinical studies using RWD submitted to FDA in support of a regulatory decision regarding the effectiveness or safety of a drug that are not subject to the IND regulations. This guidance finalizes the draft guidance of the same title issued on December 9, 2021.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2023/08/31/2023-18841.html","cfr_references":[],"citation":"88 FR 60215","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on August 31, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-D-1214"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-08-31","updated_at":"2023-08-31T10:56:34.355-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-D-1214-0033","allow_late_comments":null,"id":"FDA-2021-D-1214-0033","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2021-D-1214","title":"Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability"}],"document_number":"2023-18841","effective_on":null,"end_page":60217,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/08/31/2023-18841.xml","html_url":"https://www.federalregister.gov/documents/2023/08/31/2023-18841/considerations-for-the-use-of-real-world-data-and-real-world-evidence-to-support-regulatory","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-18841?publication_date=2023-08-31","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-08-31/2023-18841/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1554,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-08-31/pdf/2023-18841.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-18841.pdf?1693399533","publication_date":"2023-08-31","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/08/31/2023-18841.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-1214","supporting_documents_count":0,"docket_id":"FDA-2021-D-1214","document_id":"FDA-2021-D-1214-0033","regulation_id_number":null,"title":"Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-09-01T14:00:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":60215,"subtype":null,"title":"Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry; Availability","toc_doc":"Considerations for the Use of RealWorld Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}