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

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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Bibliographic Details
Main Authors: Szymon Jarosławski, Pascal Auquier, Borislav Borissov, Claude Dussart, Mondher Toumi
Format: Article
Language:English
Published: Taylor & Francis Group 2018-01-01
Series:Journal of Market Access & Health Policy
Subjects:
Patient-reported outcomes
quality of life
rare diseases
orphan drugs
labelling
Online Access:http://dx.doi.org/10.1080/20016689.2018.1433426

Internet

http://dx.doi.org/10.1080/20016689.2018.1433426

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