{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products.\" To facilitate FDA's internal tracking of submissions to the Agency that include real-world data (RWD) and real- world evidence (RWE), this guidance encourages sponsors and applicants to identify in their submission cover letters certain uses of RWD/RWE. This guidance does not address FDA's substantive review of the RWD/RWE submitted as part of the Agency's standard review process. This guidance finalizes the draft guidance entitled \"Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics\" issued on May 9, 2019.","action":"Notice of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/2022/09/09/2022-19494.html","cfr_references":[],"citation":"87 FR 55446","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on September 9, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-D-1263"],"dockets":[{"supporting_documents":[{"title":"Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products; Guidance for Industry","document_id":"FDA-2019-D-1263-0014"},{"title":"Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug Administration for Drug and Biological Products; Guidance for Industry; Availability","document_id":"FDA-2019-D-1263-0013"},{"title":"Submitting Documents Using Real-World Data and Real-World Evidence\nto FDA for Drugs and Biologics; Guidance for Industry; Draft Guidance","document_id":"FDA-2019-D-1263-0002"},{"title":"Submitting Documents Using Real-World Data and Real-World Evidence\nto the Food and Drug Administration for Drugs and Biologics; Draft Guidance for Industry; Availability","document_id":"FDA-2019-D-1263-0001"}],"agency_name":null,"documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2023-02-27T19:07:30.604-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2019-D-1263-0013","allow_late_comments":null,"id":"FDA-2019-D-1263-0013","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":4,"id":"FDA-2019-D-1263","title":"Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics; Draft Guidance for Industry; Availability"}],"document_number":"2022-19494","effective_on":null,"end_page":55447,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/09/09/2022-19494.xml","html_url":"https://www.federalregister.gov/documents/2022/09/09/2022-19494/submitting-documents-using-real-world-data-and-real-world-evidence-to-the-food-and-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-19494?publication_date=2022-09-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-09-09/2022-19494/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":509,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-09-09/pdf/2022-19494.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-19494.pdf?1662641122","publication_date":"2022-09-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/09/09/2022-19494.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products; Guidance for Industry","document_id":"FDA-2019-D-1263-0014"},{"title":"Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug Administration for Drug and Biological Products; Guidance for Industry; Availability","document_id":"FDA-2019-D-1263-0013"},{"title":"Submitting Documents Using Real-World Data and Real-World Evidence\nto FDA for Drugs and Biologics; Guidance for Industry; Draft Guidance","document_id":"FDA-2019-D-1263-0002"},{"title":"Submitting Documents Using Real-World Data and Real-World Evidence\nto the Food and Drug Administration for Drugs and Biologics; Draft Guidance for Industry; Availability","document_id":"FDA-2019-D-1263-0001"}],"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-1263","supporting_documents_count":4,"docket_id":"FDA-2019-D-1263","document_id":"FDA-2019-D-1263-0013","regulation_id_number":null,"title":"Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-02-28T00:07:29Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":55446,"subtype":null,"title":"Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug Administration for Drug and Biological Products; Guidance for Industry; Availability","toc_doc":"Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug Administration for Drug and Biological Products","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}