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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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Detalhes bibliográficos
Publicado no:J Mark Access Health Policy
Main Authors: Jarosławski, Szymon, Auquier, Pascal, Borissov, Borislav, Dussart, Claude, Toumi, Mondher
Formato: Artigo
Idioma:Inglês
Publicado em: Routledge 2018
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5956285/
https://ncbi.nlm.nih.gov/pubmed/29785254
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1080/20016689.2018.1433426
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