Negocios · 15/3/20111 min de lectura
Investigational New Drug Applications and Abbreviated New Drug Applications; Technical Amendment
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Resumen
The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulations and abbreviated new drug application regulations to correct inaccurate cross-references to the IND regulations and the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is being taken to ensure accuracy and clarity in the Agency's regulations.