{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled \"Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry.\" The draft guidance document provides sponsors engaged in the development of regenerative medicine therapies for serious or life-threatening diseases or conditions with FDA's recommendations on the expedited development and review of these therapies. This draft guidance, when finalized, will supersede the final guidance of the same title dated February 2019.","action":"Notice of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/2025/09/25/2025-18653.html","cfr_references":[],"citation":"90 FR 46225","comment_url":null,"comments_close_on":"2025-11-24","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by November 24, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2017-D-6159"],"dockets":[{"supporting_documents":[{"title":"2018-278 - Reference 6","document_id":"FDA-2017-D-6159-0027"},{"title":"2018-278 - Reference 9","document_id":"FDA-2017-D-6159-0026"},{"title":"2018-278 - Reference 8","document_id":"FDA-2017-D-6159-0025"},{"title":"2018-278 - Reference 7","document_id":"FDA-2017-D-6159-0024"},{"title":"2018-278 - Reference 5","document_id":"FDA-2017-D-6159-0023"},{"title":"2018-278 - Reference 4","document_id":"FDA-2017-D-6159-0022"},{"title":"2018-278 - reference 3","document_id":"FDA-2017-D-6159-0021"},{"title":"2018-278 - Reference 2","document_id":"FDA-2017-D-6159-0020"},{"title":"2018-278 - Reference 1","document_id":"FDA-2017-D-6159-0019"},{"title":"2018-278 - Reference cover sheet","document_id":"FDA-2017-D-6159-0018"}],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2025-09-25T11:04:47.908-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-D-6159-0031","allow_late_comments":false,"id":"FDA-2017-D-6159-0031","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":10,"id":"FDA-2017-D-6159","title":"Expedited Programs for Regenerative Medicine Therapies for Serious Conditions"}],"document_number":"2025-18653","effective_on":null,"end_page":46227,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/09/25/2025-18653.xml","html_url":"https://www.federalregister.gov/documents/2025/09/25/2025-18653/expedited-programs-for-regenerative-medicine-therapies-for-serious-conditions-draft-guidance-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-18653?publication_date=2025-09-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-09-25/2025-18653/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":911,"last_updated":"2026-08-26 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-25/pdf/2025-18653.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-18653.pdf?1758717925","publication_date":"2025-09-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/09/25/2025-18653.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"2018-278 - Reference 6","document_id":"FDA-2017-D-6159-0027"},{"title":"2018-278 - Reference 9","document_id":"FDA-2017-D-6159-0026"},{"title":"2018-278 - Reference 8","document_id":"FDA-2017-D-6159-0025"},{"title":"2018-278 - Reference 7","document_id":"FDA-2017-D-6159-0024"},{"title":"2018-278 - Reference 5","document_id":"FDA-2017-D-6159-0023"},{"title":"2018-278 - Reference 4","document_id":"FDA-2017-D-6159-0022"},{"title":"2018-278 - reference 3","document_id":"FDA-2017-D-6159-0021"},{"title":"2018-278 - Reference 2","document_id":"FDA-2017-D-6159-0020"},{"title":"2018-278 - Reference 1","document_id":"FDA-2017-D-6159-0019"},{"title":"2018-278 - Reference cover sheet","document_id":"FDA-2017-D-6159-0018"}],"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-2017-D-6159","supporting_documents_count":10,"docket_id":"FDA-2017-D-6159","document_id":"FDA-2017-D-6159-0031","regulation_id_number":null,"title":"Expedited Programs for Regenerative Medicine Therapies for Serious Conditions","checked_regulationsdotgov_at":"2025-09-27T08:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":46225,"subtype":null,"title":"Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry; Availability","toc_doc":"Expedited Programs for Regenerative Medicine Therapies for Serious Conditions","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}