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FDA’s own briefing states that 503A compounders generally are not required to report adverse events to FDA and that the agency may therefore be unaware of events unless a report is voluntarily submitted
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The compound is described in review literature as having pleiotropic activity across many tissue-injury models, with proposed mechanisms including VEGFR2/Akt-eNOS signaling, ERK1/2 phosphorylation, growth-hormone receptor upregulation, and reported downregulation of pro-inflammatory cytokines
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