{"abstract":"The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. On October 31, 2023, the Committee will discuss and make recommendations on biologics license application (BLA) 125787 from Vertex Pharmaceuticals, Inc. for exagamglogene autotemcel (exa-cel). The applicant has requested an indication for the treatment of sickle cell disease in patients 12 years and older with recurrent vaso- occlusive crises. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.","action":"Notice; establishment of a public docket; request for comments.","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/2023/09/07/2023-19284.html","cfr_references":[],"citation":"88 FR 61598","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The meeting will be held on October 31, 2023, from 9 a.m. to 5 p.m. Eastern Time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-N-1190"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":31,"comment_start_date":"2023-09-07","updated_at":"2023-11-01T01:01:22.821-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-N-1190-0173","allow_late_comments":null,"id":"FDA-2023-N-1190-0173","comment_end_date":"2023-10-31","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-N-1190","title":"Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments"}],"document_number":"2023-19284","effective_on":null,"end_page":61600,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/09/07/2023-19284.xml","html_url":"https://www.federalregister.gov/documents/2023/09/07/2023-19284/cellular-tissue-and-gene-therapies-advisory-committee-notice-of-meeting-establishment-of-a-public","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-19284?publication_date=2023-09-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-09-07/2023-19284/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":724,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-09-07/pdf/2023-19284.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-19284.pdf?1694004509","publication_date":"2023-09-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/09/07/2023-19284.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":31,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2023-N-1190","supporting_documents_count":0,"docket_id":"FDA-2023-N-1190","document_id":"FDA-2023-N-1190-0173","regulation_id_number":null,"title":"Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments","checked_regulationsdotgov_at":"2023-11-02T01:00:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":61598,"subtype":null,"title":"Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Sickle Cell Disease","toc_doc":"Cellular, Tissue, and Gene Therapies Advisory CommitteeSickle Cell Disease","toc_subject":"Meetings:\n","topics":[],"type":"Notice","volume":88}