{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance entitled \"Potency Assurance for Cellular and Gene Therapy Products.\" FDA is issuing this draft guidance to provide recommendations to help assure the potency of human cellular therapy or gene therapy (CGT) products at all stages of the product lifecycle. FDA is recommending a comprehensive approach to potency assurance of CGT products that is grounded in quality risk management. For investigational products, we describe how to progressively implement a strategy for potency assurance during product development and provide additional considerations to help assure the potency of products that are undergoing rapid clinical development. For licensed products, we describe requirements for potency assurance, including testing required for lot release.","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/2023/12/28/2023-28596.html","cfr_references":[],"citation":"88 FR 89707","comment_url":null,"comments_close_on":"2024-03-27","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by March 27, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2023-D-4299"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-12-28","updated_at":"2023-12-28T11:56:34.397-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-4299-0001","allow_late_comments":null,"id":"FDA-2023-D-4299-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-D-4299","title":"Potency Assurance for Cellular and Gene Therapy Products; Draft Guidance for Industry; Availability"}],"document_number":"2023-28596","effective_on":null,"end_page":89709,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/12/28/2023-28596.xml","html_url":"https://www.federalregister.gov/documents/2023/12/28/2023-28596/potency-assurance-for-cellular-and-gene-therapy-products-draft-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-28596?publication_date=2023-12-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-12-28/2023-28596/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1039,"last_updated":"2026-10-23 22:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-12-28/pdf/2023-28596.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-28596.pdf?1703684723","publication_date":"2023-12-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/12/28/2023-28596.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-2023-D-4299","supporting_documents_count":0,"docket_id":"FDA-2023-D-4299","document_id":"FDA-2023-D-4299-0001","regulation_id_number":null,"title":"Potency Assurance for Cellular and Gene Therapy Products; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-12-29T16:00:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":89707,"subtype":null,"title":"Potency Assurance for Cellular and Gene Therapy Products; Draft Guidance for Industry; Availability","toc_doc":"Potency Assurance for Cellular and Gene Therapy Products","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}