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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 ...