Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014).

@article{Gnanasakthy2016PatientReportedOL,
  title={Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014).},
  author={Ari Gnanasakthy and Carla Demuro and Marci J Clark and Emily E Haydysch and Esprit Ma and Vijayveer Bonthapally},
  journal={Journal of clinical oncology : official journal of the American Society of Clinical Oncology},
  year={2016},
  volume={34 16},
  pages={
          1928-34
        }
}
PURPOSE To review the use of patient-reported outcome (PRO) data in medical product labeling granted by the US Food and Drug Administration (FDA) for new molecular entities and biologic license applications by the FDA Office of Hematology and Oncology Products (OHOP) between January 2010 and December 2014, to elucidate challenges faced by OHOP for approving… CONTINUE READING