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Data from clinical trials for FDA approved medications should not be utilized to make decisions related to compounded medications

A study performed in primary cultures of OFs from GO patients and control subjects demonstrated that quercetin exerts an inhibitory effect on fibroblasts proliferation and HA release, with no difference between GO and control fibroblasts ( in vivo studies are needed to confirm this hypothesis, also considering that quercetin seems to act through necrosis, which may worsen autoimmunity against orbital antigens due to antigen exposure to the immune system

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Further studies are required to provide more evidence about the differences between RBC senescence and eryptosis

Notably, a key feature of this approval is its link to the FDAs National Priority Voucher (CNPV) program