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Description

Ohanian M, Rozovski U, Kanagal-Shamanna R, Abruzzo LV, Loghavi S, Kadia T, Futreal A, Bhalla K, Zuo Z, Huh YO, Post SM, Ruvolo P, Garcia-Manero G, Andreeff M, Kornblau S, Borthakur G , Hu P, Medeiros LJ, Takahashi K, Hornbaker MJ, Zhang J, Nogueras-Gonzlez GM, Huang X, Verstovsek S, Estrov Z, Pierce S, Ravandi F, Kantarjian HM, Bueso-Ramos CE, Cortes JE

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This includes: Product release decisions Sterility assurance Environmental monitoring Laboratory testing Stability programs Batch disposition Once confidence in data is lost, FDA must assume that the entire quality system may be compromised

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