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Most frequently cited categories in warning letters These tables illustrate that each stage of FDA requirements has critical issues that the FDA often finds are insufficient in companies

These mutations, which primarily affect IDH1 (R132), which is localized in the cytosol and peroxisomes, and IDH2 (R172), which is located in the mitochondria, lead to the accumulation of D-2-hydroxyglutarate metabolites, driving oncogenesis through widespread epigenetic dysregulation

doi: 10.1016/0165-5728(90)90094-4 277 TabaieE

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