2017-2018 Hematology Drug Approvals at the Food and Drug Administration (FDA): Communication of Patient-Reported Outcomes (PRO) Information in FDA Clinical Reviews and Prescribing Information (PI)
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DOI: 10.1182/blood-2019-125798
Abstract: Introduction: In recent years, there has been increased interest in patient experience data, including PROs. To determine how and where PRO data are being assessed and communicated as part of approval of a marketing application,… read more here.
Keywords: information; hematology; fda clinical; pro data ... See more keywords