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:
“... the yearly expenses of the existing religious system ... exceed in these United States twenty millions of dollars. Twenty millions! For teaching what? Things unseen and causes unknown!... Twenty millions would more than suffice to make us wise; and alas! do they not more than suffice to make us foolish?”
—Frances Wright (1795–1852)
“So here they are, the dog-faced soldiers, the regulars, the fifty-cents-a-day professionals riding the outposts of the nation, from Fort Reno to Fort Apache, from Sheridan to Stark. They were all the same. Men in dirty-shirt blue and only a cold page in the history books to mark their passing. But wherever they rode and whatever they fought for, that place became the United States.”
—Frank S. Nugent (1908–1965)
“I hate to do what everybody else is doing. Why, only last week, on Fifth Avenue and some cross streets, I noticed that every feminine citizen of these United States wore an artificial posy on her coat or gown. I came home and ripped off every one of the really lovely refrigerator blossoms that were sewn on my own bodices.”
—Carolyn Wells (1862–1942)
“The popular colleges of the United States are turning out more educated people with less originality and fewer geniuses than any other country.”
—Caroline Nichols Churchill (1833–?)
“Because of these convictions, I made a personal decision in the 1964 Presidential campaign to make education a fundamental issue and to put it high on the nation’s agenda. I proposed to act on my belief that regardless of a family’s financial condition, education should be available to every child in the United States—as much education as he could absorb.”
—Lyndon Baines Johnson (1908–1973)