United States
In 1979, the United States Food and Drug Administration (FDA) introduced a classification of fetal risks due to pharmaceuticals. This was based on a similar system that was introduced in Sweden one year earlier.
The United States FDA has the following definitions for the pregnancy categories:
| United States FDA Pharmaceutical Pregnancy Categories | |
| Pregnancy Category A | Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). |
| Pregnancy Category B | Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. |
| Pregnancy Category C | Animal reproduction studies have 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. |
| Pregnancy Category D | There is 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 potential risks. |
| Pregnancy Category X | 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 of the drug in pregnant women clearly outweigh potential benefits. |
| Pregnancy Category N | FDA has not classified this drug. |
One characteristic of the FDA definitions of the pregnancy categories is that the FDA requires a relatively large amount of high-quality data on a pharmaceutical for it to be defined as Pregnancy Category A. As a result of this, many drugs that would be considered Pregnancy Category A in other countries are allocated to Category C by the FDA. See below.
The FDA has proposed updating its approach to labeling http://edocket.access.gpo.gov/2008/pdf/E8-11806.pdf
Read more about this topic: Pregnancy Category
Famous quotes related to united states:
“It is said that the British Empire is very large and respectable, and that the United States are a first-rate power. We do not believe that a tide rises and falls behind every man which can float the British Empire like a chip, if he should ever harbor it in his mind.”
—Henry David Thoreau (1817–1862)
“The parallel between antifeminism and race prejudice is striking. The same underlying motives appear to be at work, namely fear, jealousy, feelings of insecurity, fear of economic competition, guilt feelings, and the like. Many of the leaders of the feminist movement in the nineteenth-century United States clearly understood the similarity of the motives at work in antifeminism and race discrimination and associated themselves with the anti slavery movement.”
—Ashley Montagu (b. 1905)
“Of all the nations in the world, the United States was built in nobody’s image. It was the land of the unexpected, of unbounded hope, of ideals, of quest for an unknown perfection. It is all the more unfitting that we should offer ourselves in images. And all the more fitting that the images which we make wittingly or unwittingly to sell America to the world should come back to haunt and curse us.”
—Daniel J. Boorstin (b. 1914)
“You are, I am sure, aware that genuine popular support in the United States is required to carry out any Government policy, foreign or domestic. The American people make up their own minds and no governmental action can change it.”
—Franklin D. Roosevelt (1882–1945)
“Nova Scotia, New Brunswick, and Canada are the horns, the head, the neck, the shins, and the hoof of the ox, and the United States are the ribs, the sirloin, the kidneys, and the rest of the body.”
—William Cobbett (1762–1835)