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Immunonutrition: the role of taurine

Researchers must also generate non-clinical evidence demonstrating that the compound interacts with the intended target and produces the expected pharmacological effects without showing major safety concerns

Registry data and findings from other studies suggest that combination therapy with AEDs may increase the risk of teratogenic effects compared to monotherapy with an AED

STTR BAAs and CSOs use a letter instead of a number after the fiscal year designation so 21.A is the first STTR BAA during fiscal year 2021

Not for use in newborns due to benzyl alcohol toxicity profile in neonates