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The insertion of selenocysteine (Sec) during translation involves a unique set of specialized translational cofactors, including a Sec-specific elongation factor, a tRNA Sec that recognizes the UGA codon, and RNA binding proteins, such as SBP2 (SECIS binding protein 2) that bind to stem-loop structures in the 3’-untranslated region of the selenoprotein transcripts denoted selenocysteine incorporation sequence or SECIS (for review see [64, 65])
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One affirmative voter summarized the legal distinction: “Our duty is to apply the 503A standards, not the investigational new drug application standard.” The member emphasized that inclusion would not approve a drug or indication
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