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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 ...
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) ...