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Penticoff, H., and J

Category 2 placement: The FDA placed TB-500 (Thymosin Beta-4 Fragment, LKKTETQ) in Category 2 of the 503A bulk drug substances list, citing significant safety concerns

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The high sensitivity but lower specificity of the HepG2 cell model with hamster S9-mix therefore makes the model useful when a conservative approach to avoid false-negative results is the goal of the test strategy

Regular blood testing allows potential issues to be identified early so that any necessary treatment or further testing can begin without delay