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:
“What chiefly distinguishes the daily press of the United States from the press of all other countries is not its lack of truthfulness or even its lack of dignity and honor, for these deficiencies are common to the newspapers everywhere, but its incurable fear of ideas, its constant effort to evade the discussion of fundamentals by translating all issues into a few elemental fears, its incessant reduction of all reflection to mere emotion. It is, in the true sense, never well-informed.”
—H.L. (Henry Lewis)
“God knows that any man who would seek the presidency of the United States is a fool for his pains. The burden is all but intolerable, and the things that I have to do are just as much as the human spirit can carry.”
—Woodrow Wilson (1856–1924)
“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)
“In the larger view the major forces of the depression now lie outside of the United States, and our recuperation has been retarded by the unwarranted degree of fear and apprehension created by these outside forces.”
—Herbert Hoover (1874–1964)
“I thought it altogether proper that I should take a brief furlough from official duties at Washington to mingle with you here to-day as a comrade, because every President of the United States must realize that the strength of the Government, its defence in war, the army that is to muster under its banner when our Nation is assailed, is to be found here in the masses of our people.”
—Benjamin Harrison (1833–1901)