{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, investigators, and other stakeholders entitled \"Decentralized Clinical Trials for Drugs, Biological Products, and Devices.\" This draft guidance provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. In this draft guidance, a DCT refers to a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites.","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/2023/05/03/2023-09399.html","cfr_references":[],"citation":"88 FR 27900","comment_url":null,"comments_close_on":"2023-08-01","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by August 1, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-D-2870"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-05-03","updated_at":"2024-09-18T09:56:14.359-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-D-2870-0001","allow_late_comments":false,"id":"FDA-2022-D-2870-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-D-2870","title":"Decentralized Clinical Trials for Drugs, Biological Products, and Devices; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability"}],"document_number":"2023-09399","effective_on":null,"end_page":27901,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/05/03/2023-09399.xml","html_url":"https://www.federalregister.gov/documents/2023/05/03/2023-09399/decentralized-clinical-trials-for-drugs-biological-products-and-devices-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-09399?publication_date=2023-05-03","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-05-03/2023-09399/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":2202,"last_updated":"2026-04-03 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-05-03/pdf/2023-09399.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-09399.pdf?1683031536","publication_date":"2023-05-03","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/05/03/2023-09399.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-2022-D-2870","supporting_documents_count":0,"docket_id":"FDA-2022-D-2870","document_id":"FDA-2022-D-2870-0001","regulation_id_number":null,"title":"Decentralized Clinical Trials for Drugs, Biological Products, and Devices; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability","checked_regulationsdotgov_at":"2024-09-19T13:00:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27900,"subtype":null,"title":"Decentralized Clinical Trials for Drugs, Biological Products, and Devices; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability","toc_doc":"Decentralized Clinical Trials for Drugs, Biological Products, and Devices","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}