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Nevins JEH, Donovan SM, Snetselaar L, et al

If a biological product was previously licensed under a different regulatory pathway (e.g., as a biologics license application converted from an NDA during the transition of protein products to biologics regulation), the first licensure date may significantly predate the current BLA holders commercial launch

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J Nanobiotechnol 15:112 Squires JE, Berry MJ (2008) Eukaryotic selenoprotein synthesis: mechanistic insight incorporating new factors and new functions for old factors