{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a document entitled \"Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products\" dated January 2011. The guidance document provides manufacturers of cellular and gene therapy (CGT) products with recommendations for developing tests to measure potency. The recommendations are intended to clarify the potency information that could support an investigational new drug application (IND) or a biologics license application (BLA). The guidance announced in this notice finalizes the draft guidance of the same title dated October 2008.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services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/2011/02/16/2011-3462.html","cfr_references":[],"citation":"76 FR 9028","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on Agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2008-D-0520"],"dockets":[],"document_number":"2011-3462","effective_on":null,"end_page":9028,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2011/02/16/2011-3462.xml","html_url":"https://www.federalregister.gov/documents/2011/02/16/2011-3462/guidance-for-industry-potency-tests-for-cellular-and-gene-therapy-products-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2011-3462?publication_date=2011-02-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2011-02-16/2011-3462/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":859,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2011-02-16/pdf/2011-3462.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2011-02-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2011/02/16/2011-3462.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-03-08T08:05:54Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":9028,"subtype":null,"title":"Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products; Availability","toc_doc":"Potency Tests for Cellular and Gene Therapy Products","toc_subject":"Guidance for Industry; Availability:","topics":[],"type":"Notice","volume":76}