Abstract

Patient reported outcome (PRO) data is being used to support labeling claims of products’ effects on patients’ functional status, experience of care, symptoms and symptom burden, and health related quality of life (HRQoL). This study reviewed PRO information reported in labels for novel drug approvals (NDAs) approved from 2016 to 2021 and compared findings to previously published results from 2006 to 2015.

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