Analysis of the first ten years of FDA’s rare pediatric disease priority review voucher program: designations, diseases, and drug development

Abstract Background The Rare Pediatric Disease (RPD) Priority Review Voucher (PRV) Program was enacted in 2012 to support the development of new products for children. Prior to requesting a voucher, applicants can request RPD designation, which confirms their product treats or prevents a rare diseas...

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Autors principals:	Catherine Mease, Kathleen L. Miller, Lewis J. Fermaglich, Jeanine Best, Gumei Liu, Erika Torjusen
Format:	Artigo
Idioma:	Inglês
Publicat:	BMC 2024-02-01
Col·lecció:	Orphanet Journal of Rare Diseases
Matèries:	Rare pediatric diseases Food and Drug Administration Children Designations Drug development
Accés en línia:	https://doi.org/10.1186/s13023-024-03097-x
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