{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled \"Frequently asked Questions--Developing Potential Cellular and Gene Therapy Products.\" The guidance document provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products. The FAQs represent common questions directed to the Agency and span multiple disciplines, including regulatory review; chemistry, manufacturing, and controls (CMC); pharmacology/toxicology; clinical; and clinical pharmacology. This guidance announced in this notice finalizes the draft guidance of the same title issued on November 19, 2024.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2026/08/20/2026-16959.html","cfr_references":[],"citation":"91 FR 53879","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on August 20, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-D-4311"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-08-20","updated_at":"2026-08-20T09:57:36.130-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-D-4311-0025","allow_late_comments":false,"id":"FDA-2024-D-4311-0025","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-D-4311","title":"Frequently Asked Questions – Cellular and Gene Therapy Products; Draft Guidance for Industry; Availability"}],"document_number":"2026-16959","effective_on":null,"end_page":53880,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/08/20/2026-16959.xml","html_url":"https://www.federalregister.gov/documents/2026/08/20/2026-16959/frequently-asked-questions-developing-potential-cellular-and-gene-therapy-products-final-guidance","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-16959?publication_date=2026-08-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-08-20/2026-16959/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":788,"last_updated":"2026-10-24 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-20/pdf/2026-16959.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16959.pdf?1787143517","publication_date":"2026-08-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/08/20/2026-16959.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-2024-D-4311","supporting_documents_count":0,"docket_id":"FDA-2024-D-4311","document_id":"FDA-2024-D-4311-0025","regulation_id_number":null,"title":"Frequently Asked Questions – Cellular and Gene Therapy Products; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2026-08-21T16:55:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":53879,"subtype":null,"title":"Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry; Availability","toc_doc":"Frequently Asked QuestionsDeveloping Potential Cellular and Gene Therapy Products","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}