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={A. Gnanasakthy and C. Demuro and M. Clark and E. Haydysch and E. Ma and V. Bonthapally},
  journal={Journal of clinical oncology : official journal of the American Society of Clinical Oncology},
  year={2016},
  volume={34 16},
  pages={
          1928-34
        }
}
  • A. Gnanasakthy, C. Demuro, +3 authors V. Bonthapally
  • Published 2016
  • Medicine
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • 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 PRO labeling, and to understand challenges faced by drug manufacturers to include PRO end points in oncology clinical trials. METHODS FDA… CONTINUE READING
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