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Geschäft · 7.4.20151 Min. Lesezeit
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
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 (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that UNITUXIN (dinutuximab), manufactured by United Therapeutics Corporation, meets the criteria for a priority review voucher.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →