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Research with human subjects is typically subject to the regulations of the Food and Drug Administration (FDA) if an "investigational new drug" (IND), "investigational device exemption" (IDE), or use of other biologics, biological products, food, food additives, or nutritional supplements are involved. Specific criteria have been set by the FDA (21 CFR 50.3) for determination of what research is subject to the FDA regulations that govern research with human subjects.