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A review of perfos in fda and ema labelling claims (2009-2019)
(Elsevier Science Inc, New York, 2019)
Disease specific patient-reported outcome (pro) instruments for hematologic malignancies (hm)
(Elsevier Science Inc, New York, 2019)
Patient-reported outcomes used in clinical trials of systemic lupus erythematosus: a review of suitability for FDA labelling claims
(Elsevier Science Inc, New York, 2019)
PCR43 A Review of Migraine-Related Pros in FDA Labelling Claims (2018-2023)
(Elsevier, 2023)
Objective
The objective of this review was to characterize the inclusion of migraine patient-reported outcomes (PROs) in FDA approvals subsequent the FDA’s release in 2018 of the Patient Focused Drug Development (PFDD) ...
Overview of COA Measures in SLE Clinical Trials and Label Claims
(Elsevier, 2023)
Background
Systematic lupus erythematosus (SLE) is a condition linked with high symptom burden and severe quality of life (QoL) impacts. The FDA and EMA SLE guidance recommends inclusion of clinical outcome assessments ...