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Negócios · 01/11/20021 min de leitura
Guidance for Industry on Immunotoxicology Evaluation of Investigational New Drugs; Availability
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Resumo
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Immunotoxicology Evaluation of Investigational New Drugs." This guidance provides recommendations for sponsors of investigational new drugs (INDs) on what parameters to routinely assess in toxicology studies to determine effects on immune function, when to conduct additional immunotoxicity studies, and when additional mechanistic information could better characterize a given effect on the immune system.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →