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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Bibliographic Details
Main Authors: Szymon Jarosławski (Author), Pascal Auquier (Author), Borislav Borissov (Author), Claude Dussart (Author), Mondher Toumi (Author)
Format: Book
Published: Taylor & Francis Group, 2018-01-01T00:00:00Z.
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3rd Floor Main Library

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Call Number: A1234.567
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