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 veto is a President’s Constitutional right, given to him by the drafters of the Constitution because they wanted it as a check against irresponsible Congressional action. The veto forces Congress to take another look at legislation that has been passed. I think this is a responsible tool for a president of the United States, and I have sought to use it responsibly.”
—Gerald R. Ford (b. 1913)
“In the United States adherence to the values of the masculine mystique makes intimate, self-revealing, deep friendships between men unusual.”
—Myriam Miedzian, U.S. author. Boys Will Be Boys, introduction (1991)
“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)
“The United States is just now the oldest country in the world, there always is an oldest country and she is it, it is she who is the mother of the twentieth century civilization. She began to feel herself as it just after the Civil War. And so it is a country the right age to have been born in and the wrong age to live in.”
—Gertrude Stein (1874–1946)
“America—rather, the United States—seems to me to be the Jew among the nations. It is resourceful, adaptable, maligned, envied, feared, imposed upon. It is warm-hearted, overfriendly; quick-witted, lavish, colorful; given to extravagant speech and gestures; its people are travelers and wanderers by nature, moving, shifting, restless; swarming in Fords, in ocean liners; craving entertainment; volatile. The schnuckle among the nations of the world.”
—Edna Ferber (1887–1968)