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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| 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/10.1080/20016689.2018.1433426 |
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