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the exact sourcing model and pharmaceutical classification (503A vs

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Separately, a spokesperson for FDA's Center for Drug Evaluation and Research , said it was possible compounded semaglutide is exempt from normal FDA approval if it is "made using a bulk drug substance (active ingredient) that is a component of an FDA-approved human drug product, provided all other conditions

This research offers further insight into this emerging safety signal, according to the study authors who noted in their Ophthalmology paper, Our novel, stratified analysis provides a more nuanced interpretation than previous pooled reviews, isolating a potential increased risk signal to observational data in the diabetes population only, a finding not corroborated by RCTs. These results are somewhat at odds with the narrative surrounding GLP-1 use and NAION risk that began in early 2024, but the researchers say they are confident in their methodology

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