{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled \"Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry.\" The draft guidance document discusses methods and approaches for capturing postapproval safety and efficacy data for cell and gene therapy (CGT) products. Given the potential for long-lasting effects of CGT products, and the generally limited number of participants treated in clinical trials, the collection of postapproval study data for CGT products is important for gathering data on product safety and effectiveness over time.","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/2025/09/25/2025-18650.html","cfr_references":[],"citation":"90 FR 46223","comment_url":null,"comments_close_on":"2025-12-24","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by December 24, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2025-D-3049"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2025-09-25T11:56:25.667-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-D-3049-0001","allow_late_comments":false,"id":"FDA-2025-D-3049-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-D-3049","title":"Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry; Availability"}],"document_number":"2025-18650","effective_on":null,"end_page":46225,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/09/25/2025-18650.xml","html_url":"https://www.federalregister.gov/documents/2025/09/25/2025-18650/postapproval-methods-to-capture-safety-and-efficacy-data-for-cell-and-gene-therapy-products-draft","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-18650?publication_date=2025-09-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-09-25/2025-18650/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":546,"last_updated":"2026-07-27 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-25/pdf/2025-18650.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-18650.pdf?1758717924","publication_date":"2025-09-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/09/25/2025-18650.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-2025-D-3049","supporting_documents_count":0,"docket_id":"FDA-2025-D-3049","document_id":"FDA-2025-D-3049-0001","regulation_id_number":null,"title":"Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2025-09-26T18:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":46223,"subtype":null,"title":"Postapproval Methods To Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry; Availability","toc_doc":"Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}