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 comprehensi...
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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 |