{"abstract":"The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect comments on a framework created by the Center for Drug Evaluation and Research and the Center for Biologic Evaluation and Research for implementing a program to evaluate the potential use of real-world evidence (RWE) in regulatory decision making. This framework is entitled \"Framework for the Real-World Evidence Program.\" The 21st Century Cures Act (Cures Act) was enacted on December 13, 2016, and requires that FDA establish a framework for implementing a program to evaluate the potential use of RWE to help support the approval of a new indication for a drug approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to help support or satisfy postapproval study requirements. FDA has created this framework to satisfy the Cures Act mandate and is establishing a docket to receive public comments.","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/2018/12/07/2018-26546.html","cfr_references":[],"citation":"83 FR 63178","comment_url":null,"comments_close_on":"2019-02-05","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft document by February 5, 2019 to ensure that the Agency considers your comment before it begins work to implement the program.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-4000"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":31,"comment_start_date":"2018-12-07","updated_at":"2023-02-28T21:09:02.733-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-N-4000-0001","allow_late_comments":null,"id":"FDA-2018-N-4000-0001","comment_end_date":"2019-02-06","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2018-N-4000","title":"Framework for a Real-World Evidence Program; Availability "}],"document_number":"2018-26546","effective_on":null,"end_page":63179,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/12/07/2018-26546.xml","html_url":"https://www.federalregister.gov/documents/2018/12/07/2018-26546/framework-for-a-real-world-evidence-program-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-26546?publication_date=2018-12-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-12-07/2018-26546/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":3792,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-12-07/pdf/2018-26546.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-26546.pdf?1544103920","publication_date":"2018-12-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/12/07/2018-26546.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":31,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-N-4000","supporting_documents_count":0,"docket_id":"FDA-2018-N-4000","document_id":"FDA-2018-N-4000-0001","regulation_id_number":null,"title":"Framework for a Real-World Evidence Program; Availability ","checked_regulationsdotgov_at":"2023-03-01T02:09:01Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":63178,"subtype":null,"title":"Framework for a Real-World Evidence Program; Availability","toc_doc":"Framework for a Real-World Evidence Program","toc_subject":null,"topics":[],"type":"Notice","volume":83}