Low rates of patient-reported outcome claims for orphan drugs approved by the us food and drug administration

• Autori principali: Szymon Jarosławski (Autore), Pascal Auquier (Autore), Borislav Borissov (Autore), Claude Dussart (Autore), Mondher Toumi (Autore)
• Natura: Libro
• Pubblicazione: Taylor & Francis Group, 2018-01-01T00:00:00Z.
• Soggetti: article
• Accesso online: Connect to this object online.

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...