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Again, the agency would have to show that any such proposal was appropriate for protecting public health, based on a consideration of the risks and benefits to the population as a whole

33 FDAs assessment comprises several different reviews: Regulatory Engineering Chemical Microbiology Toxicology Behavioral and clinical pharmacology Medical Epidemiology Social science Environmental science Bioresearch monitoring Manufacturing compliance These reviews feed into eight thematic assessments that are used to evaluate the product against the APPH standard: Product comparisons Product characteristics Abuse liability User populations Toxicant exposure Health effects Population and public health Statutory compliance Additionally, an environmental assessment is required

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