{"abstract":"The Food and Drug Administration (FDA) is announcing the approval of a product redeeming a rare pediatric disease priority review voucher. 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 issuance of rare pediatric disease priority review vouchers as well as the approval of products redeeming vouchers. FDA has determined that AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted), BLA supplement approved June 7, 2024, meets the criteria for redeeming 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/2026/04/16/2026-07368.html","cfr_references":[],"citation":"91 FR 20460","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-3446"],"dockets":[],"document_number":"2026-07368","effective_on":null,"end_page":20460,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/04/16/2026-07368.xml","html_url":"https://www.federalregister.gov/documents/2026/04/16/2026-07368/notice-of-approval-of-product-under-voucher-rare-pediatric-disease-priority-review-voucher-arexvy","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-07368?publication_date=2026-04-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-04-16/2026-07368/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":33,"last_updated":"2026-04-16 16:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-16/pdf/2026-07368.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07368.pdf?1776257113","publication_date":"2026-04-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/04/16/2026-07368.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-3446","supporting_documents_count":0,"docket_id":"FDA-2026-N-3446","document_id":"FDA-2026-N-3446-0001","regulation_id_number":null,"title":"Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted)","checked_regulationsdotgov_at":"2026-04-16T18:05:48Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":20460,"subtype":null,"title":"Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted)","toc_doc":"Rare Pediatric Disease; Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted)","toc_subject":"Priority Review Voucher","topics":[],"type":"Notice","volume":91}