{"abstract":"The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that WASKYRA (etuvetidigene autotemcel), approved on December 9, 2025, manufactured by Fondazione Telethon ETS, meets the criteria for a priority review voucher.","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/2026/02/23/2026-03493.html","cfr_references":[],"citation":"91 FR 8494","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-0672"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2026-02-23T10:00:10.966-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-0672-0001","allow_late_comments":false,"id":"FDA-2026-N-0672-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-N-0672","title":"Issuance of Priority Review Voucher; Rare Pediatric Disease Product; WASKYRA (etuvetidigene autotemcel)"}],"document_number":"2026-03493","effective_on":null,"end_page":8494,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/02/23/2026-03493.xml","html_url":"https://www.federalregister.gov/documents/2026/02/23/2026-03493/issuance-of-priority-review-voucher-rare-pediatric-disease-product-waskyra-etuvetidigene-autotemcel","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-03493?publication_date=2026-02-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-02-23/2026-03493/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":199,"last_updated":"2026-04-04 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-23/pdf/2026-03493.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-03493.pdf?1771595116","publication_date":"2026-02-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/02/23/2026-03493.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-2026-N-0672","supporting_documents_count":0,"docket_id":"FDA-2026-N-0672","document_id":"FDA-2026-N-0672-0001","regulation_id_number":null,"title":"Issuance of Priority Review Voucher; Rare Pediatric Disease Product; WASKYRA (etuvetidigene autotemcel)","checked_regulationsdotgov_at":"2026-02-24T18:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":8494,"subtype":null,"title":"Issuance of Priority Review Voucher; Rare Pediatric Disease Product; WASKYRA (etuvetidigene autotemcel)","toc_doc":"Waskyra","toc_subject":"Issuance of Priority Review Voucher; Rare Pediatric Disease Product","topics":[],"type":"Notice","volume":91}