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FDA Pregnancy Cate.

FDA Pregnancy Category

QuestionAnswer
What Pregnancy Category is adequate and well controlled studies to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in the later trimester)? Category A
What Pregnancy Category has animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well controlled studies in pregnant women? Category B
What Pregnancy Category has animal reproduction studies shown an adverse effect on the fetus and there are no adequate and well controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks? Category C
What Pregnancy Category is there a positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potenti Category D
What Pregnancy Category has the FDA not classified the drug? Category N
What Pregnancy Category has studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use Category X
Created by: hrivas013