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Low rates of patient-reported outcome claims for orphan drugs approved by the us food and drug administration

Background: Claims included in package inserts (PIs) for medicinal products approved by the US Food and Drug Administration (FDA) constitute the regulatory definition of drugs’ benefits and risks. Objective: We sought to assess the usage of patient-reported outcome (PRO) claims in a comprehensive se...

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Detalles Bibliográficos
Autores principales:	Jarosławski, Szymon, Auquier, Pascal, Borissov, Borislav, Dussart, Claude, Toumi, Mondher
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Routledge 2018
Materias:	Original Research Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5956285/ https://www.ncbi.nlm.nih.gov/pubmed/29785254 http://dx.doi.org/10.1080/20016689.2018.1433426

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