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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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Príomhchruthaitheoirí: Catherine Mease, Kathleen L. Miller, Lewis J. Fermaglich, Jeanine Best, Gumei Liu, Erika Torjusen
Formáid: Artigo
Teanga:Inglês
Foilsithe / Cruthaithe: BMC 2024-02-01
Sraith:Orphanet Journal of Rare Diseases
Ábhair:
Rochtain ar líne:https://doi.org/10.1186/s13023-024-03097-x
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