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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Format: | Book |
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Taylor & Francis Group,
2018-01-01T00:00:00Z.
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Internet
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A1234.567 |
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Copy 1 | Available |