Jennifer J Ross

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A sponsor developing a vaccine or related product for clinical study in the U.S. must submit an Investigational New Drug Application (IND) to the Food and Drug Administration (FDA). Evaluation of information submitted to the IND may prompt a clinical hold, for reasons described in 21 CFR 312.42. Our review of clinical hold letters issued to sponsors during(More)
Food products in the United States (U.S.), including dietary supplements, may contain live microorganisms and can be promoted for general health, nutritional, or structure/function claims. In contrast, such preparations used with the intention of having a preventive or therapeutic effect in humans are regulated by the Food and Drug Administration (FDA) in(More)
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