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)
“The rising power of the United States in world affairs ... requires, not a more compliant press, but a relentless barrage of facts and criticism.... Our job in this age, as I see it, is not to serve as cheerleaders for our side in the present world struggle but to help the largest possible number of people to see the realities of the changing and convulsive world in which American policy must operate.”
—James Reston (b. 1909)
“On the whole, yes, I would rather be the Chief Justice of the United States, and a quieter life than that which becomes at the White House is more in keeping with the temperament, but when taken into consideration that I go into history as President, and my children and my children’s children are the better placed on account of that fact, I am inclined to think that to be President well compensates one for all the trials and criticisms he has to bear and undergo.”
—William Howard Taft (1857–1930)
“We now in the United States have more security guards for the rich than we have police services for the poor districts. If you’re looking for personal security, far better to move to the suburbs than to pay taxes in New York.”
—John Kenneth Galbraith (b. 1908)
“As a Tax-Paying Citizen of the United States I am entitled to a voice in Governmental affairs.... Having paid this unlawful Tax under written Protest for forty years, I am entitled to receive from the Treasury of ‘Uncle Sam’ the full amount of both Principal and Interest.”
—Susan Pecker Fowler (1823–1911)