{"abstract":"The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures 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 award of the priority review voucher. FDA has determined that VEKLURY (remdesivir), manufactured by Gilead Sciences, Inc., meets the criteria for a material threat MCM 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/2022/04/29/2022-09233.html","cfr_references":[],"citation":"87 FR 25491","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2019-N-0895"],"dockets":[],"document_number":"2022-09233","effective_on":null,"end_page":25491,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/04/29/2022-09233.xml","html_url":"https://www.federalregister.gov/documents/2022/04/29/2022-09233/issuance-of-priority-review-voucher-material-threat-medical-countermeasure-product","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-09233?publication_date=2022-04-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-04-29/2022-09233/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":714,"last_updated":"2026-10-22 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-04-29/pdf/2022-09233.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-09233.pdf?1651150010","publication_date":"2022-04-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/04/29/2022-09233.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure  Priority Review Voucher","document_id":"FDA-2019-N-0895-0008"},{"title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product","document_id":"FDA-2019-N-0895-0007"},{"title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product","document_id":"FDA-2019-N-0895-0006"},{"title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product","document_id":"FDA-2019-N-0895-0005"},{"title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product","document_id":"FDA-2019-N-0895-0004"},{"title":"ssuance of Priority Review Voucher; \nMaterial Threat Medical \nCountermeasure Product","document_id":"FDA-2019-N-0895-0003"},{"title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product","document_id":"FDA-2019-N-0895-0002"},{"title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product","document_id":"FDA-2019-N-0895-0001"}],"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-2019-N-0895","supporting_documents_count":8,"docket_id":"FDA-2019-N-0895","document_id":"FDA-2019-N-0895-0006","regulation_id_number":null,"title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product","checked_regulationsdotgov_at":"2022-04-30T03:30:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":25491,"subtype":null,"title":"Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product","toc_doc":"Material Threat Medical Countermeasure Product","toc_subject":"Priority Review Voucher:\n","topics":[],"type":"Notice","volume":87}