Food and Drug Administration guidelines for reproductive toxicity testing.
The Food and Drug Administration generally requires reproductive toxicity testing of all new drugs to be used by pregnant women or women or men of reproductive potential. These requirements may vary among the centers within the FDA. Reproductive and developmental toxicity is usually tested in one or two animal species and is divided into three segments to represent treatment throughout the reproductive process. The FDA monitors adverse drug effects on human reproduction through postmarketing surveillance.
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Division of Metabolism and Endocrine Drug Products, Food and Drug Administration, Rockville, MD 20857.
Jordan
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Fourcroy
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D002986:Clinical Trials as Topic; D004341:Drug Evaluation; D015507:Drugs, Investigational; D005260:Female; D006801:Humans; D008297:Male; D011247:Pregnancy; D012098:Reproduction / Q000187:drug effects*; D014481:United States; D014486:United States Food and Drug Administration
D015507:Drugs, Investigational