Guidelines of the Food and Drug Administration for Study of New Drugs in Human Subjects

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The Food and Drug Administration recently has published general guidelines for the clinical evaluation of drugs used in adults and in infants and children. Specific guidelines for a number of drug classes, including anti-infective drugs, are also available. Marketing approval of a new drug requires that its benefits be judged to exceed its risks, that it be accurately and truthfully labeled, and that it be manufactured properly. Foreign studies are commonly accepted in support of new drugs, but approval requires at least one domestic trial unless the disease does not occur in the United States (for example, tropical diseases).

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