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This distinction matters because FDA approval involves a formal review of safety, effectiveness, manufacturing quality, labeling, and intended use
Cui M, Li Y, Zheng T, Chen H, Wang J, Feng Y, et al
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Friedreichs ataxia: clinical features, pathogenesis and management
The peptide restored normal heart rhythm in 85% of subjects with experimentally induced arrhythmias (Drmic et al., Biomedicine & Pharmacotherapy, 2018)
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