{"abstract":"The Food and Drug Administration (FDA) is announcing the approval of a product redeeming a material threat medical countermeasure (MCM) priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the issuance of material threat MCM priority review vouchers as well as the approval of products redeeming a voucher. FDA has determined that FABHALTA (iptacopan) capsules, approved December 5, 2023, meets the redemption criteria.","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/2024/01/16/2024-00688.html","cfr_references":[],"citation":"89 FR 2624","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2024-N-0065"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-01-16","updated_at":"2024-01-16T12:56:03.072-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-N-0065-0001","allow_late_comments":null,"id":"FDA-2024-N-0065-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-N-0065","title":"Notice of Approval of Product under Voucher: Material Threat Medical Countermeasure (MCM) Priority Review Voucher"}],"document_number":"2024-00688","effective_on":null,"end_page":2624,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/01/16/2024-00688.xml","html_url":"https://www.federalregister.gov/documents/2024/01/16/2024-00688/notice-of-approval-of-product-under-voucher-material-threat-medical-countermeasure-priority-review","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-00688?publication_date=2024-01-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-01-16/2024-00688/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":455,"last_updated":"2026-10-24 18:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-01-16/pdf/2024-00688.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-00688.pdf?1705067129","publication_date":"2024-01-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/01/16/2024-00688.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-N-0065","supporting_documents_count":0,"docket_id":"FDA-2024-N-0065","document_id":"FDA-2024-N-0065-0001","regulation_id_number":null,"title":"Notice of Approval of Product under Voucher: Material Threat Medical Countermeasure (MCM) Priority Review Voucher","checked_regulationsdotgov_at":"2024-01-17T20:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":2624,"subtype":null,"title":"Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher; FABHALTA","toc_doc":"Material Threat Medical Countermeasure Priority Review Voucher; Fabhalta","toc_subject":"Approval of Product under Voucher:\n","topics":[],"type":"Notice","volume":89}