Patient-reported outcome claims in European and United States orphan drug approvals
Purpose: We aimed to evaluate the rate of usage and the kind of patient-reported outcome (PRO) claims in orphan drug approvals from the European Medicines Agency (EMA) dated between 1/1/2012 and 31/12/2016 and to compare them to those from the US Food and Drug Administration (FDA). Methods: Orphan d...
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| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2018-01-01
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| Series: | Journal of Market Access & Health Policy |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/20016689.2018.1542920 |
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