The Census Bureau had gone from two categories to how many by the 1990s?

By 1990, the Census Bureau included more than a dozen ethnic/racial categories on the census, reflecting not only changing social ideas about ethnicity, but the wide variety of immigrants who had come to reside in the United States due to changing historical forces and new immigration laws in the 1960s. With a changing society, more citizens have begun to press for acknowledging multiracial ancestry. The Census Bureau changed its data collection by allowing people to self-identify as more than one ethnicity. Some ethnic groups are concerned about the potential political and economic effects, as federal assistance to historically underserved groups has depended on Census data. According to the Census Bureau, as of 2002, over 75% of all African Americans had multiracial ancestries.


By 2002, what percent of African Americans had multiracial ancestries?


Why were there more immigrants in the US?


How had the Census Bureau changed its collection of data?


What is one of the many outcomes of the Census data?


How many different ethnic categories were listed on the modern census?


Can people self identify as more than one ethnicity on the US census currently?


About how many African American have multiracial ancestries


Do some ethnic groups have concerns about census changes?


How is some federal assistance allocated to certain groups?


Twelve or more categories for race and ethnicity were in the Census by when?


When did laws allow for more immigrants?


How many African Americans identify as multiracial on the Census of 2002?


What type of federal assistance depends on Census data?


Americans with African ancestry have always been classified as what race?

Americans with Sub-Saharan African ancestry for historical reasons: slavery, partus sequitur ventrem, one-eighth law, the one-drop rule of 20th-century legislation, have frequently been classified as black (historically) or African American, even if they have significant European American or Native American ancestry. As slavery became a racial caste, those who were enslaved and others of any African ancestry were classified by what is termed "hypodescent" according to the lower status ethnic group. Many of majority European ancestry and appearance "married white" and assimilated into white society for its social and economic advantages, such as generations of families identified as Melungeons, now generally classified as white but demonstrated genetically to be of European and sub-Saharan African ancestry.


What were slaves and others of African ancestry classified by what term?


Melungeons are generally classified as white but what are they genetically what other races?


What did many with European ancetry "marry white" and want to be part of the white society?


Which Americans have been historically classified as African American or black?


What caused lower classification status for African Americans?


How did many multiracial Americans attain social and economic advantages?


What are some historical reasons multiracial Americans have been classified as black?


What is the group called who are genetically sub Saharan and European but are classified as white?


What does it mean to have "marred white"?


What were those with Sub-Saharan African ancestory classified as?


What were slaves and Africans classified by?


What is the effect of there no longer being a stigma on interracial marriage?

After a lengthy period of formal racial segregation in the former Confederacy following the Reconstruction Era, and bans on interracial marriage in various parts of the country, more people are openly forming interracial unions. In addition, social conditions have changed and many multiracial people do not believe it is socially advantageous to try to "pass" as white. Diverse immigration has brought more mixed-race people into the United States, such as the large population of Hispanics identifying as mestizos. Since the 1980s, the United States has had a growing multiracial identity movement (cf. Loving Day). Because more Americans have insisted on being allowed to acknowledge their mixed racial origins, the 2000 census for the first time allowed residents to check more than one ethno-racial identity and thereby identify as multiracial. In 2008 Barack Obama was elected as the first multiracial President of the United States; he acknowledges both sides of his family and identifies as African American.


What has caused more people of mixed races to the US?


When was there a period of formal racial segregation?


Who was elected and was the first multiracial president of the United States?


Why were Americans allowed to start checking more than one box to identify their race in the Census in 200?


Who was the first multiracial president elected in the US


When did the US begin to experience a growing multiracial identity movement?


When did the US census start to allow residents to mark more than one ethno-racial identity on the census form?


What has brought more mixed race people to the US?


What was it once considered socially advantageous to do?


What is an example of the multiracial identity movement at work?


What does the first multiracial president identify as?


When did the census begin allowing multiple boxes to be checked?


When was an African American president elected?


What were put in place to prevent the mix of races?

Anti-miscegenation laws were passed in most states during the 18th, 19th and early 20th centuries, but this did not prevent white slaveholders, their sons, or other powerful white men from taking slave women as concubines and having multiracial children with them. In California and the western US, there were greater numbers of Latino and Asian residents. These were prohibited from official relationships with whites. White legislators passed laws prohibiting marriage between European and Asian Americans until the 1950s.


Why did the anti-miscegenation not insure that there was no interracial mixing?


Where was there greater numbers of Latinos and Asian residents?


When were the laws against marriage between Asians and Europeans lifted?


What races were prohibited from official relationships with whites?


When were anti-miscegenation laws passed?


Were Latino residents also prohibited from marrying whites?


Did these laws change behavior of white slaveholders and other powerful white men?


Which region has greater numbers of Latino and Asian residents?


Were there any laws against marriage between whites and Asians in the US?


In the western US, who were not allowed to have relationships with whites?


When did laws stop banning marriage between whites and asians?


When did the numbers of free people of color increase dramatically?

After the American Revolutionary War, the number and proportion of free people of color increased markedly in the North and the South as slaves were freed. Most northern states abolished slavery, sometimes, like New York, in programs of gradual emancipation that took more than two decades to be completed. The last slaves in New York were not freed until 1827. In connection with the Second Great Awakening, Quaker and Methodist preachers in the South urged slaveholders to free their slaves. Revolutionary ideals led many men to free their slaves, some by deed and others by will, so that from 1782 to 1810, the percentage of free people of color rose from less than one percent to nearly 10 percent of blacks in the South.


How were the laws in New York abolished?


How long did it take for states like New York to abolish all slave laws?


Who in the south were urging their churches to free their slaves in the south?


When were the last slaves freed in New York state?


When did the number of free people of color begin to increase in the North and South?


Who implored slaveholders to free their slaves?


What caused many slaveholder to free their slaves?


How much did the percentage of free people in the South change from 1782 to 1810?


What is it called when it takes several years for slaves to be freed in a program?


The last slave in New York was freed when?


What caused Quaker and Methodist preachers to want to free slaves?


In 1810, how many black people were considered free?


What caused many men to free slaves from 1782 to 1810?


In their attempt to ensure white supremacy decades after emancipation, in the early 20th century, most southern states created laws based on the one-drop rule, defining as black, persons with any known African ancestry. This was a stricter interpretation than what had prevailed in the 19th century; it ignored the many mixed families in the state and went against commonly accepted social rules of judging a person by appearance and association. Some courts called it "the traceable amount rule." Anthropologists called it an example of a hypodescent rule, meaning that racially mixed persons were assigned the status of the socially subordinate group.


What did some courts call the one-drop rule?


Why were laws like the one drop rule enacted?


What made the one drop rule stricter than rules in the 19th century?


In the early 1900s, what was did black mean in southern states?


Prior to the 1900s, what was the socially accepted rule for racial interpretation?


What rule means multiracial people are given status of the socially subordinate group?


What was the rule used in law in the 1900s called?


Approximentally how many Americans identified themselves as multiracial in the 2010 US census?

Multiracial Americans are Americans who have mixed ancestry of "two or more races". The term may also include Americans of mixed-race ancestry who self-identify with just one group culturally and socially (cf. the one-drop rule). In the 2010 US census, approximately 9 million individuals, or 2.9% of the population, self-identified as multiracial. There is evidence that an accounting by genetic ancestry would produce a higher number, but people live according to social and cultural identities, not DNA. Historical reasons, including slavery creating a racial caste and the European-American suppression of Native Americans, often led people to identify or be classified by only one ethnicity, generally that of the culture in which they were raised. Prior to the mid-20th century, many people hid their multiracial heritage because of racial discrimination against minorities. While many Americans may be biologically multiracial, they often do not know it or do not identify so culturally, any more than they maintain all the differing traditions of a variety of national ancestries.


Why did muticultural Americans hid their heritage?


Before the mid-20th century were people open about their muticultural heritage and why or why not?


Are all muticultural Americans aware of their cultural heritage?


What is the accepted definition of "multicultural" ancestry?


Which cultural do multicultural people usually identify with?


Are all multicultural Americans aware of their heritage?


How many multiracial people in the US were there in 2010?


When did people stop hiding mutliracial heritage?


What are people most likely to identify themselves as?


Would DNA show a higher number or lower number of mutliracial people than those reported in the census?


The American people are mostly multi-ethnic descendants of various culturally distinct immigrant groups, many of which have now developed nations. Some consider themselves multiracial, while acknowledging race as a social construct. Creolization, assimilation and integration have been continuing processes. The African-American Civil Rights Movement (1955–1968) and other social movements since the mid-twentieth century worked to achieve social justice and equal enforcement of civil rights under the constitution for all ethnicities. In the 2000s, less than 5% of the population identified as multiracial. In many instances, mixed racial ancestry is so far back in an individual's family history (for instance, before the Civil War or earlier), that it does not affect more recent ethnic and cultural identification.


How much of the population identified as mixed race in the 2000s?


Who are descendents of various culturally distinct groups?


What does affect recent identification in many cases?


Some Europeans living among Indigenous Americans were called "white Indians". They "lived in native communities for years, learned native languages fluently, attended native councils, and often fought alongside their native companions." More numerous and typical were traders and trappers, who married Indigenous American women from tribes on the frontier and had families with them. Some traders, who kept bases in the cities, had what ware called "country wives" among Indigenous Americans, with legal European-American wives and children at home in the city. Not all abandoned their "natural" mixed-race children. Some arranged for sons to be sent to European-American schools for their education.


Who lived in native communities, speaking the language and participating in the affairs of tribes?


Why were some multiracial children sent to Europe?


When could white women and black men be in a union?

In the colonial years, while conditions were more fluid, white women, indentured servant or free, and African men, servant, slave or free, made unions. Because the women were free, their mixed-race children were born free; they and their descendants formed most of the families of free people of color during the colonial period in Virginia. The scholar Paul Heinegg found that eighty percent of the free people of color in North Carolina in censuses from 1790–1810 could be traced to families free in Virginia in colonial years.


Where did 80% of free people of color in NC come from?


Who were not identified by name on the census before the civil war?

Sometimes people of mixed African-American and Native American descent report having had elder family members withholding pertinent genealogical information. Tracing the genealogy of African Americans can be a very difficult process, as censuses did not identify slaves by name before the American Civil War, meaning that most African Americans did not appear by name in those records. In addition, many white fathers who used slave women sexually, even those in long-term relationships like Thomas Jefferson's with Sally Hemings, did not acknowledge their mixed-race slave children in records, so paternity was lost.


Who was Thomas Jefferson in a relationship with?


Not recognizing white fatherhood for multiracial slave children cause what to be lost?


Who will not reveal full ancestral data to mixed race people?


Who brought Christian missionaries to Hawaii?

During the 1800s Christian missionaries from Great Britain and the United States followed traders to the Hawaiian islands. Long-termly, the Anglo-Saxon presence negatively impacted the level of regard Hawaiian royal women held for their own indigenous looks. For centuries prior the arrival of Christians, first nation Hawaiian aesthetics, such as dark skin and ample bodies, had been considered signs of nobility. No matter how much they adapted their mannerisms to Western standard, some of the Anglo-Saxon missionaries were relentless in referring to the indigenous women as "Hawaiian squaws." By the last half of the 19th century, some Hawaiian women began marrying European men who found them exotic. The men, however, selected Hawaiian women who were thinner and paler in complexion.


What cause royal Hawaiian females to find themselves ugly?


What are some examples of how a noble person should look before Christians came?


What did westerners call the women of Hawaii?


When would white men marry the paler and thinner Hawaiian ladies?


Who are blamed in this paragraph for Jim Crow laws?

Racial discrimination continued to be enacted in new laws in the 20th century, for instance the one-drop rule was enacted in Virginia's 1924 Racial Integrity Law and in other southern states, in part influenced by the popularity of eugenics and ideas of racial purity. People buried fading memories that many whites had multiracial ancestry. Many families were multiracial. Similar laws had been proposed but not passed in the late nineteenth century in South Carolina and Virginia, for instance. After regaining political power in Southern states by disenfranchising blacks, white Democrats passed laws to impose Jim Crow and racial segregation to restore white supremacy. They maintained these until forced to change in the 1960s and after by enforcement of federal legislation authorizing oversight of practices to protect the constitutional rights of African Americans and other minority citizens.


When did Virginia add the one drop rule to their laws?


Why were laws limiting people of color passed?


What had popularity in the early 20th century that caused rising racial discrimination?


What fact was ignored by enacting one-drop rule laws?


A person is not a member of a racial minority if ancetry does not what?

The phenomenon known as "passing as white" is difficult to explain in other countries or to foreign students. Typical questions are: "Shouldn't Americans say that a person who is passing as white is white, or nearly all white, and has previously been passing as black?" or "To be consistent, shouldn't you say that someone who is one-eighth white is passing as black?" ... A person who is one-fourth or less American Indian or Korean or Filipino is not regarded as passing if he or she intermarries with and joins fully the life of the dominant community, so the minority ancestry need not be hidden. ... It is often suggested that the key reason for this is that the physical differences between these other groups and whites are less pronounced than the physical differences between African blacks and whites, and therefore are less threatening to whites. ... [W]hen ancestry in one of these racial minority groups does not exceed one-fourth, a person is not defined solely as a member of that group.


Who are consdered to have the most physical differences?


What are groups other than blacks considered to be?


Who says genetic tests can't tell the difference between different Native American nations?

Population testing is still being done. Some Native American groups that have been sampled may not have shared the pattern of markers being searched for. Geneticists acknowledge that DNA testing cannot yet distinguish among members of differing cultural Native American nations. There is genetic evidence for three major migrations into North America, but not for more recent historic differentiation. In addition, not all Native Americans have been tested, so scientists do not know for sure that Native Americans have only the genetic markers they have identified.


Some multiracial individuals feel marginalized by U.S. society. For example, when applying to schools or for a job, or when taking standardized tests, Americans are sometimes asked to check boxes corresponding to race or ethnicity. Typically, about five race choices are given, with the instruction to "check only one." While some surveys offer an "other" box, this choice groups together individuals of many different multiracial types (ex: European Americans/African-Americans are grouped with Asian/Native American Indians).


How many racial choices are there on standardized tests?


How many race choices may someone check?


When do mixed race individuals feel marginalized?


What usually played a larger role than laws regarding a person's race?

Prior to the one-drop rule, different states had different laws regarding color. More importantly, social acceptance often played a bigger role in how a person was perceived and how identity was construed than any law. In frontier areas, there were fewer questions about origins. The community looked at how people performed, whether they served in the militia and voted, which were the responsibilities and signs of free citizens. When questions about racial identity arose because of inheritance issues, for instance, litigation outcomes often were based on how people were accepted by neighbors.


Where did people not ask about racial background?


What were the hallmarks of free citizens?


Whos acceptance decided inheritance issues?


The President's father is from what country?

Since the late twentieth century, the number of African and Caribbean ethnic African immigrants have increased in the United States. Together with publicity about the ancestry of President Barack Obama, whose father was from Kenya, some black writers have argued that new terms are needed for recent immigrants. They suggest that the term "African-American" should refer strictly to the descendants of African slaves and free people of color who survived the slavery era in the United States. They argue that grouping together all ethnic Africans regardless of their unique ancestral circumstances would deny the lingering effects of slavery within the American slave descendant community. They say recent ethnic African immigrants need to recognize their own unique ancestral backgrounds.


What community still has some effects of slavery?


What must Africans who recently immigrated do?


Who argue for a term other than African American to describe recent immigrants?


When did multiracial people start to organize for more inclusive racial identifiers?

In the 1980s, parents of mixed-race children began to organize and lobby for the addition of a more inclusive term of racial designation that would reflect the heritage of their children. When the U.S. government proposed the addition of the category of "bi-racial" or "multiracial" in 1988, the response from the public was mostly negative. Some African-American organizations, and African-American political leaders, such as Congresswoman Diane Watson and Congressman Augustus Hawkins, were particularly vocal in their rejection of the category, as they feared the loss of political and economic power if African Americans reduced their numbers by self-identification.


What was the response to the idea of identifying people as biracial or multiracial?


What could have cause loss of power via the use of the term biracial and multiracial?


Who are some of the opponents of biracial and multiracial as identifiers?


What determined a child's social identity?

The social identity of the children was strongly determined by the tribe's kinship system. Among the matrilineal tribes of the Southeast, the mixed-race children generally were accepted as and identified as Indian, as they gained their social status from their mother's clans and tribes, and often grew up with their mothers and their male relatives. By contrast, among the patrilineal Omaha, for example, the child of a white man and Omaha woman was considered "white"; such mixed-race children and their mothers would be protected, but the children could formally belong to the tribe as members only if adopted by a man.


What heritage system do Southeast tribes use?


What were multiracial children with a tribal mother considered to be in tribes of the Southeast?


What race did the Omaha view a multiracial child with a white father to be?


How could a white child be considered a member of the Omaha tribe?


In the late 19th century, three European-American middle-class female teachers married Indigenous American men they had met at Hampton Institute during the years when it ran its Indian program. In the late nineteenth century, Charles Eastman, a physician of European and Sioux ancestry who trained at Boston University, married Elaine Goodale, a European-American woman from New England. They met and worked together in Dakota Territory when she was Superintendent of Indian Education and he was a doctor for the reservations. His maternal grandfather was Seth Eastman, an artist and Army officer from New England, who had married a Sioux woman and had a daughter with her while stationed at Fort Snelling in Minnesota.


Who did the relative of the doctor marry?


Who met their husbands at the Hampton institute?


Who said many African Americans have NAtive American heritage?

The writer Sherrel W. Stewart's assertion that "most" African Americans have significant Native American heritage, is not supported by genetic researchers who have done extensive population mapping studies. The TV series on African-American ancestry, hosted by the scholar Henry Louis Gates, Jr., had genetics scholars who discussed in detail the variety of ancestries among African Americans. They noted there is popular belief in a high rate of Native American admixture that is not supported by the data that has been collected. (Reference is coming)


Who hosts a TV series on the genetic history of African Americans?


What jobs did the earliest Europeans who mingled with natives hold?

Interracial relationships have had a long history in North America and the United States, beginning with the intermixing of European explorers and soldiers, who took native women as companions. After European settlement increased, traders and fur trappers often married or had unions with women of native tribes. In the 17th century, faced with a continuing, critical labor shortage, colonists primarily in the Chesapeake Bay Colony, imported Africans as laborers, sometimes as indentured servants and, increasingly, as slaves. African slaves were also imported into New York and other northern ports by the Dutch and later English. Some African slaves were freed by their masters during these early years.


Who started marrying or having unions with native women after settlment increased?


Why did Chesapeake Bay colonists begin to buy slaves?


President Thomas Jefferson had a relationship with who?

Of numerous relationships between male slaveholders, overseers, or master's sons and women slaves, the most notable is likely that of President Thomas Jefferson with his slave Sally Hemings. As noted in the 2012 collaborative Smithsonian-Monticello exhibit, Slavery at Monticello: The Paradox of Liberty, Jefferson, then a widower, took Hemings as his concubine for nearly 40 years. They had six children of record; four Hemings children survived into adulthood, and he freed them all, among the very few slaves he freed. Two were allowed to "escape" to the North in 1822, and two were granted freedom by his will upon his death in 1826. Seven-eighths white by ancestry, all four of his Hemings children moved to northern states as adults; three of the four entered the white community, and all their descendants identified as white. Of the descendants of Madison Hemings, who continued to identify as black, some in future generations eventually identified as white and "married out", while others continued to identify as African American. It was socially advantageous for the Hemings children to identify as white, in keeping with their appearance and the majority proportion of their ancestry. Although born into slavery, the Hemings children were legally white under Virginia law of the time.


What was the name of the Smithsonian-Monticello exhibit that discussed their relationship?


How long were Jefferson and Hemmings in a relationship?


Which child of Jefferson identified as black?


How much of the children of Jefferson and Hemmings were white?


As an example, whose status was downgraded after the civil war?

After the Civil War, racial segregation forced African Americans to share more of a common lot in society than they might have given widely varying ancestry, educational and economic levels. The binary division altered the separate status of the traditionally free people of color in Louisiana, for instance, although they maintained a strong Louisiana Créole culture related to French culture and language, and practice of Catholicism. African Americans began to create common cause—regardless of their multiracial admixture or social and economic stratification. In 20th-century changes, during the rise of the Civil Rights and Black Power movements, the African-American community increased its own pressure for people of any portion of African descent to be claimed by the black community to add to its power.


Who were increasingly included as African Americans in the 20th century?


Where did most Chinese men enter the US?

Chinese men entered the United States as laborers, primarily on the West Coast and in western territories. Following the Reconstruction era, as blacks set up independent farms, white planters imported Chinese laborers to satisfy their need for labor. In 1882, the Chinese Exclusion Act was passed, and Chinese workers who chose to stay in the U.S. were unable to have their wives join them. In the South, some Chinese married into the black and mulatto communities, as generally discrimination meant they did not take white spouses. They rapidly left working as laborers, and set up groceries in small towns throughout the South. They worked to get their children educated and socially mobile.


What cause wives to be unable to move to the US with their Chinese husbands after 1882?


What did racial bias generally mean for Chinese people?


What did Chinese laborers do after they left that line of work?


What office is responsible for the census form changes?

Multiracial people who wanted to acknowledge their full heritage won a victory of sorts in 1997, when the Office of Management and Budget (OMB) changed the federal regulation of racial categories to permit multiple responses. This resulted in a change to the 2000 United States Census, which allowed participants to select more than one of the six available categories, which were, in brief: "White," "Black or African American," "Asian," "American Indian or Alaskan Native," "Native Hawaiian or other Pacific Islander," and "Other." Further details are given in the article: Race (U.S. census). The OMB made its directive mandatory for all government forms by 2003.


When did the OMB change racial guidelines for the census form?


What did the OMB vote to allow on the 2000 census?


When were the OMB racial directive made mandatory for every government form?


What was the result of a child having an African mother?

Laws dating from 17th-century colonial America defined children of African slave mothers as taking the status of their mothers, and born into slavery regardless of the race or status of the father, under partus sequitur ventrem. The association of slavery with a "race" led to slavery as a racial caste. But, most families of free people of color formed in Virginia before the American Revolution were the descendants of unions between white women and African men, who frequently worked and lived together in the looser conditions of the early colonial period. While interracial marriage was later prohibited, white men frequently took sexual advantage of slave women, and numerous generations of multiracial children were born. By the late 1800s it had become common among African Americans to use passing to gain educational opportunities as did the first African-American graduate of Vassar College Anita Florence Hemmings. Some 19th-century categorization schemes defined people by proportion of African ancestry: a person whose parents were black and white was classified as mulatto, with one black grandparent and three white as quadroon, and with one black great-grandparent and the remainder white as octoroon. The latter categories remained within an overall black or colored category, but before the Civil War, in Virginia and some other states, a person of one-eighth or less black ancestry was legally white. Some members of these categories passed temporarily or permanently as white.


What is the rule that allows children with white fathers to be slaves?


Who was the first African American to gradute from Vassar College?


What does a person have to have to be an octoroon?


Why did Steele think people were not attacking Barrack Obama?

Reacting to media criticism of Michelle Obama during the 2008 presidential election, Charles Kenzie Steele, Jr., CEO of the Southern Christian Leadership Conference said, "Why are they attacking Michelle Obama, and not really attacking, to that degree, her husband? Because he has no slave blood in him." He later claimed his comment was intended to be "provocative" but declined to expand on the subject. Former Secretary of State Condoleezza Rice (who was famously mistaken for a "recent American immigrant" by French President Nicolas Sarkozy), said "descendants of slaves did not get much of a head start, and I think you continue to see some of the effects of that." She has also rejected an immigrant designation for African Americans and instead prefers the term "black" or "white" .


What does Condoleeza Rice prefer to term people as?


What did President Sarkozy think Secretary of State Rice was?


When was the wedding of Rolfe and Pocahontas?

Some early male settlers married Indigenous American women and had informal unions with them. Early contact between Indigenous Americans and Europeans was often charged with tension, but also had moments of friendship, cooperation, and intimacy. Marriages took place in both English and Latin colonies between European men and Native women. For instance, on April 5, 1614, Pocahontas, a Powhatan woman in present-day Virginia, married the Englishman John Rolfe of Jamestown. Their son Thomas Rolfe was an ancestor to many descendants in First Families of Virginia. As a result, English laws did not exclude people with some Indigenous American ancestry from being considered English or white.


What did English laws not exclude people with some native blood from being?


Who was an ancestor of the First Families of Virginia?


What has helped geneologists researching slaves?

Colonial records of French and Spanish slave ships and sales, and plantation records in all the former colonies, often have much more information about slaves, from which researchers are reconstructing slave family histories. Genealogists have begun to find plantation records, court records, land deeds and other sources to trace African-American families and individuals before 1870. As slaves were generally forbidden to learn to read and write, black families passed along oral histories, which have had great persistence. Similarly, Native Americans did not generally learn to read and write English, although some did in the nineteenth century. Until 1930, census enumerators used the terms free people of color and mulatto to classify people of apparent mixed race. When those terms were dropped, as a result of the lobbying by the Southern Congressional bloc, the Census Bureau used only the binary classifications of black or white, as was typical in segregated southern states.


What were slaves usually not allowed to do?


What replaced written records for black families?


Who caused the Census Burea to drop the terms free people of color and mulatto?


When were the terms mulatto and free people of color taken off the census?


Who did colonists ask for help in returning runaway slaves?

European colonists created treaties with Indigenous American tribes requesting the return of any runaway slaves. For example, in 1726, the British governor of New York exacted a promise from the Iroquois to return all runaway slaves who had joined them. This same promise was extracted from the Huron Nation in 1764, and from the Delaware Nation in 1765, though there is no record of slaves ever being returned. Numerous advertisements requested the return of African Americans who had married Indigenous Americans or who spoke an Indigenous American language. The primary exposure that Africans and Indigenous Americans had to each other came through the institution of slavery. Indigenous Americans learned that Africans had what Indigenous Americans considered 'Great Medicine' in their bodies because Africans were virtually immune to the Old-World diseases that were decimating most native populations. Because of this, many tribes encouraged marriage between the two groups, to create stronger, healthier children from the unions.


When was a treaty with the Iroquis made to return slaves?


What asked for the return of slaves who married indigenous americans or spoke their language?


How did natives and Africans come to know each other?


Why did natives consider Africans to have a 'Great Medicine'?


What did the laws passed in the 17th century do?

Interracial relationships, common-law marriages, and marriages occurred since the earliest colonial years, especially before slavery hardened as a racial caste associated with people of African descent in the British colonies. Virginia and other English colonies passed laws in the 17th century that gave children the social status of their mother, according to the principle of partus sequitur ventrem, regardless of the father's race or citizenship. This overturned the principle in English common law by which a man gave his status to his children – this had enabled communities to demand that fathers support their children, whether legitimate or not. The change increased white men's ability to use slave women sexually, as they had no responsibility for the children. As master as well as father of mixed-race children born into slavery, the men could use these people as servants or laborers or sell them as slaves. In some cases, white fathers provided for their multiracial children, paying or arranging for education or apprenticeships and freeing them, particularly during the two decades following the American Revolution. (The practice of providing for the children was more common in French and Spanish colonies, where a class of free people of color developed who became educated and property owners.) Many other white fathers abandoned the mixed-race children and their mothers to slavery.


What is the rule called that causes a father's race to not matter?


What did white fathers do after the American Revolution to provide for mixed children?


Many Latin American migrants have been mestizo, Amerindian, or other mixed race. Multiracial Latinos have limited media appearance; critics have accused the U.S. Hispanic media of overlooking the brown-skinned indigenous and multiracial Hispanic and black Hispanic populations by over-representation of blond and blue/green-eyed white Hispanic and Latino Americans (who resemble Scandinavians and other Northern Europeans rather than they look like white Hispanic and Latino Americans mostly of typical Southern European features), and also light-skinned mulatto and mestizo Hispanic and Latino Americans (often deemed as white persons in U.S. Hispanic and Latino populations if achieving the middle class or higher social status), especially some of the actors on the telenovelas.


What do latinos consider a light skinned mulatto to be?


Who is overlooking darker skinned latino multiracial people?


What does the typical latino in media look like?


Before 1920, how would a person be white by law?

In Virginia prior to 1920, for example, a person was legally white if having seven-eights or more white ancestry. The one-drop rule originated in some Southern United States in the late 19th century, likely in response to whites' attempt to maintain white supremacy and limit black political power following the Democrats' regaining control of state legislatures in the late 1870s. The first year in which the U.S. Census dropped the mulatto category was 1920; that year enumerators were instructed to classify people in a binary way as white or black. This was a result of the Southern-dominated Congress convincing the Census Bureau to change its rules.


What year was mulatto left off the US Census?


Who is responsible for the Census Bureau discarding the mulatto category?


Who wrote an article in the New York Dail News about Obama?

Stanley Crouch wrote in a New York Daily News piece "Obama's mother is of white U.S. stock. His father is a black Kenyan," in a column entitled "What Obama Isn't: Black Like Me." During the 2008 campaign, the African-American columnist David Ehrenstein of the LA Times accused white liberals of flocking to Obama because he was a "Magic Negro", a term that refers to a black person with no past who simply appears to assist the mainstream white (as cultural protagonists/drivers) agenda. Ehrenstein went on to say "He's there to assuage white 'guilt' they feel over the role of slavery and racial segregation in American history."


What did David Ehrenstein call Obama in 2008?


What did Ehrenstein say Obama does for white people?


The 2000 U.S. Census in the write-in response category had a code listing which standardizes the placement of various write-in responses for automatic placement within the framework of the U.S. Census's enumerated races. Whereas most responses can be distinguished as falling into one of the five enumerated races, there remains some write-in responses which fall into the "Mixture" heading which cannot be racially categorized. These include "Bi Racial, Combination, Everything, Many, Mixed, Multi National, Multiple, Several and Various".


What year did the US Census write in response category have a code-listing?


What is considered to be neglected in American history?

Interracial relations between Indigenous Americans and African Americans is a part of American history that has been neglected. The earliest record of African and Indigenous American relations in the Americas occurred in April 1502, when the first Africans kidnapped were brought to Hispaniola to serve as slaves. Some escaped, and somewhere inland on Santo Domingo, the first Black Indians were born. In addition, an example of African slaves' escaping from European colonists and being absorbed by Indigenous Americans occurred as far back as 1526. In June of that year, Lucas Vasquez de Ayllon established a Spanish colony near the mouth of the Pee Dee River in what is now eastern South Carolina. The Spanish settlement was named San Miguel de Gualdape. Amongst the settlement were 100 enslaved Africans. In 1526, the first African slaves fled the colony and took refuge with local Indigenous Americans.


When is it recorded that Africans and natives interacted earliest?


Where did Africans escape and mate with naitves?


Where did Ayllon lay down a Spanish colony?


How many slaves were at San Miguel de Gualdape at its inception?


Some biographical accounts include the autobiography Life on the Color Line: The True Story of a White Boy Who Discovered He Was Black by Gregory Howard Williams; One Drop: My Father's Hidden Life—A Story of Race and Family Secrets written by Bliss Broyard about her father Anatole Broyard; the documentary Colored White Boy about a white man in North Carolina who discovers that he is the descendant of a white plantation owner and a raped African slave; and the documentary on The Sanders Women of Shreveport, Louisiana.


Gregory Howard Williams wrote what type of book?


What documentary features a white man in North Carolina?


When did people lobby for allowing more than one category to be selected on legal forms?

By the 1980s, parents of mixed-race children (and adults of mixed-race ancestry) began to organize and lobby for the ability to show more than one ethnic category on Census and other legal forms. They refused to be put into just one category. When the U.S. government proposed the addition of the category of "bi-racial" or "multiracial" in 1988, the response from the general public was mostly negative. Some African-American organizations and political leaders, such as Senator Diane Watson and Representative Augustus Hawkins, were particularly vocal in their rejection of the category. They feared a loss in political and economic power if African Americans abandoned their one category.


How did the public react to the categories of "bi-racial" and "multiracial"?


Which political leaders spoke out against the proposed designations?


In the early 19th century, the Indigenous American woman Sacagawea, who would help translate for and guide the Lewis and Clark Expedition in the West, married the French trapper Toussaint Charbonneau. Most marriages between Europeans and Indigenous Americans were between European men and Indigenous American women. Depending on the kinship system of the woman's tribe, their children would be more or less easily assimilated into the tribe. Nations that had matrilineal systems, such as the Creek and Cherokee in the Southeast, gave the mixed-race children status in their mother's clans and tribes. If the tribe had a patrilineal system, like the Omaha, the children of white fathers were considered white. Unless they were specifically adopted into the tribe by an adult male, they could have no social status in it.


Who made up most unions between Europeans and natives?


What factor affected the ability of a child to be in a tribe?


What nations are considered matrilineal?


How could a white child be considered a member of the Omaha tribe?


What brought African Americans together?

For African Americans, the one-drop rule was a significant factor in ethnic solidarity. African Americans generally shared a common cause in society regardless of their multiracial admixture, or social/economic stratification. Additionally, African Americans found it, near, impossible to learn about their Indigenous American heritage as many family elders withheld pertinent genealogical information. Tracing the genealogy of African Americans can be a very difficult process, especially for descendants of Indigenous Americans, because African Americans who were slaves were forbidden to learn to read and write, and a majority of Indigenous Americans neither spoke English, nor read or wrote it.


Who made it next to impossible to learn about their heritage for African Americans?


What did Indigenous Americans not do that makes it difficult to trace their heritage?


What factors did not affect racial solidarity amoung African Americans?


What stock character lived with her white father until he left the picture?

The figure of the "tragic octoroon" was a stock character of abolitionist literature: a mixed-race woman raised as if a white woman in her white father's household, until his bankruptcy or death has her reduced to a menial position She may even be unaware of her status before being reduced to victimization. The first character of this type was the heroine of Lydia Maria Child's "The Quadroons" (1842), a short story. This character allowed abolitionists to draw attention to the sexual exploitation in slavery and, unlike portrayals of the suffering of the field hands, did not allow slaveholders to retort that the sufferings of Northern mill hands were no easier. The Northern mill owner would not sell his own children into slavery.


Who was the first to use the tragic octoroon?


What story was written by Child in 1842?


What does the tragic octoroon point out?


Who used the figure of the tragic octoroon?


By the 1890s the profound effect of adrenal extracts on many different tissue types had been discovered, setting off a search both for the mechanism of chemical signalling and efforts to exploit these observations for the development of new drugs. The blood pressure raising and vasoconstrictive effects of adrenal extracts were of particular interest to surgeons as hemostatic agents and as treatment for shock, and a number of companies developed products based on adrenal extracts containing varying purities of the active substance. In 1897 John Abel of Johns Hopkins University identified the active principle as epinephrine, which he isolated in an impure state as the sulfate salt. Industrial chemist Jokichi Takamine later developed a method for obtaining epinephrine in a pure state, and licensed the technology to Parke Davis. Parke Davis marketed epinephrine under the trade name Adrenalin. Injected epinephrine proved to be especially efficacious for the acute treatment of asthma attacks, and an inhaled version was sold in the United States until 2011 (Primatene Mist). By 1929 epinephrine had been formulated into an inhaler for use in the treatment of nasal congestion.


Who developed the method to obtain epinephrine in a pure state?


What trade name was epinephrine marketed under?


As an inhaler, what was epinephrine used to treat?


Who developed the method to get epinephrine in it's pure form?


When did epinephrine stop being available in the United States?


In what year was epinephrine discovered?


In what year was Primatene Mist no longer sold in the United States?


While highly effective, the requirement for injection limited the use of norepinephrine[clarification needed] and orally active derivatives were sought. A structurally similar compound, ephedrine, was identified by Japanese chemists in the Ma Huang plant and marketed by Eli Lilly as an oral treatment for asthma. Following the work of Henry Dale and George Barger at Burroughs-Wellcome, academic chemist Gordon Alles synthesized amphetamine and tested it in asthma patients in 1929. The drug proved to have only modest anti-asthma effects, but produced sensations of exhilaration and palpitations. Amphetamine was developed by Smith, Kline and French as a nasal decongestant under the trade name Benzedrine Inhaler. Amphetamine was eventually developed for the treatment of narcolepsy, post-encepheletic parkinsonism, and mood elevation in depression and other psychiatric indications. It received approval as a New and Nonofficial Remedy from the American Medical Association for these uses in 1937 and remained in common use for depression until the development of tricyclic antidepressants in the 1960s.


What are common side effects of Amphetamine?


When were tricyclic antidepressants developed?


Ephedrine was used as an oral medicine for what illness?


In what year was amphetamine first tested on asthma patients?


What was the trade name of amphetamine as a nasal decongestant?


In what year did the American Medical Association approve amphetamine for medical use?


In what decade were tricyclic antidepressants created?


A series of experiments performed from the late 1800s to the early 1900s revealed that diabetes is caused by the absence of a substance normally produced by the pancreas. In 1869, Oskar Minkowski and Joseph von Mering found that diabetes could be induced in dogs by surgical removal of the pancreas. In 1921, Canadian professor Frederick Banting and his student Charles Best repeated this study, and found that injections of pancreatic extract reversed the symptoms produced by pancreas removal. Soon, the extract was demonstrated to work in people, but development of insulin therapy as a routine medical procedure was delayed by difficulties in producing the material in sufficient quantity and with reproducible purity. The researchers sought assistance from industrial collaborators at Eli Lilly and Co. based on the company's experience with large scale purification of biological materials. Chemist George Walden of Eli Lilly and Company found that careful adjustment of the pH of the extract allowed a relatively pure grade of insulin to be produced. Under pressure from Toronto University and a potential patent challenge by academic scientists who had independently developed a similar purification method, an agreement was reached for non-exclusive production of insulin by multiple companies. Prior to the discovery and widespread availability of insulin therapy the life expectancy of diabetics was only a few months.


Before insulin, what was the life expectancy of diabetics?


Who discovered that pancreatic extract reversed symptoms of pancreas removal?


Diabetes is caused by the removal of what organ?


Left untreated, how long were diabetic patients were expected to live?


What could be adjusted in a sample of pancreatic extract to produce purer insulin?


To purify insulin, Banting and Best sought the assistance of what company?


Minkowski and von Mering did surgical tests on what animal?


In 1903 Hermann Emil Fischer and Joseph von Mering disclosed their discovery that diethylbarbituric acid, formed from the reaction of diethylmalonic acid, phosphorus oxychloride and urea, induces sleep in dogs. The discovery was patented and licensed to Bayer pharmaceuticals, which marketed the compound under the trade name Veronal as a sleep aid beginning in 1904. Systematic investigations of the effect of structural changes on potency and duration of action led to the discovery of phenobarbital at Bayer in 1911 and the discovery of its potent anti-epileptic activity in 1912. Phenobarbital was among the most widely used drugs for the treatment of epilepsy through the 1970s, and as of 2014, remains on the World Health Organizations list of essential medications. The 1950s and 1960s saw increased awareness of the addictive properties and abuse potential of barbiturates and amphetamines and led to increasing restrictions on their use and growing government oversight of prescribers. Today, amphetamine is largely restricted to use in the treatment of attention deficit disorder and phenobarbital in the treatment of epilepsy.


Who discovered a reaction that induced sleep in dogs?


Why was barbiturates and amphetamines restricted?


What compound was discovered to induce sleep?


What was the first trade name of diethylbarbituric acid?


What is phenobarbital mainly used to treat today?


In what year was phenobarbital discovered?


What was Veronal used for when Bayer put it on the market?


In 1911 arsphenamine, the first synthetic anti-infective drug, was developed by Paul Ehrlich and chemist Alfred Bertheim of the Institute of Experimental Therapy in Berlin. The drug was given the commercial name Salvarsan. Ehrlich, noting both the general toxicity of arsenic and the selective absorption of certain dyes by bacteria, hypothesized that an arsenic-containing dye with similar selective absorption properties could be used to treat bacterial infections. Arsphenamine was prepared as part of a campaign to synthesize a series of such compounds, and found to exhibit partially selective toxicity. Arsphenamine proved to be the first effective treatment for syphilis, a disease which prior to that time was incurable and led inexorably to severe skin ulceration, neurological damage, and death.[citation needed]


What was the first effective treatment for Syphilis?


What complications are associated with Syphilis?


Where is the Institute of Experimental Therapy located?


Bacterial infections could be treated with medicines containing what kind of dye?


What was the name of the first synthetic bacterial drug?


Arsphenamine became the first treatment for what previously incurable disease?


In what year was arsphenamine discovered?


What was the commercial name of arsphenamine?


When was Morphine and Quinine first available?

The modern pharmaceutical industry traces its roots to two sources. The first of these were local apothecaries that expanded from their traditional role distributing botanical drugs such as morphine and quinine to wholesale manufacture in the mid 1800s. Rational drug discovery from plants started particularly with the isolation of morphine, analgesic and sleep-inducing agent from opium, by the German apothecary assistant Friedrich Sertürner, who named the compound after the Greek god of dreams, Morpheus. Multinational corporations including Merck, Hoffman-La Roche, Burroughs-Wellcome (now part of Glaxo Smith Kline), Abbott Laboratories, Eli Lilly and Upjohn (now part of Pfizer) began as local apothecary shops in the mid-1800s. By the late 1880s, German dye manufacturers had perfected the purification of individual organic compounds from coal tar and other mineral sources and had also established rudimentary methods in organic chemical synthesis. The development of synthetic chemical methods allowed scientists to systematically vary the structure of chemical substances, and growth in the emerging science of pharmacology expanded their ability to evaluate the biological effects of these structural changes.


Who is responsible for purification of compounds found in mineral sources?


Morphine was named after what Greek god?


Burroughs-Wellcome is now part of what medical company?


What is the name of the plant that produces morphine?


Who received the Nobel Prize in Medicine in 1939?

Ehrlich’s approach of systematically varying the chemical structure of synthetic compounds and measuring the effects of these changes on biological activity was pursued broadly by industrial scientists, including Bayer scientists Josef Klarer, Fritz Mietzsch, and Gerhard Domagk. This work, also based in the testing of compounds available from the German dye industry, led to the development of Prontosil, the first representative of the sulfonamide class of antibiotics. Compared to arsphenamine, the sulfonamides had a broader spectrum of activity and were far less toxic, rendering them useful for infections caused by pathogens such as streptococci. In 1939, Domagk received the Nobel Prize in Medicine for this discovery. Nonetheless, the dramatic decrease in deaths from infectious diseases that occurred prior to World War II was primarily the result of improved public health measures such as clean water and less crowded housing, and the impact of anti-infective drugs and vaccines was significant mainly after World War II.


Who is responsible for creating Prontosil?


Many deaths occurred before World War II due to what?


What was the name of the first sulfonamine antibiotic?


Anti-infective drugs became more prominent after what war?


Were sulfonamides more or less toxic than arsphenamine?


Streptococci and other pathogens could be treated by what type of antibiotics?


Early progress toward the development of vaccines occurred throughout this period, primarily in the form of academic and government-funded basic research directed toward the identification of the pathogens responsible for common communicable diseases. In 1885 Louis Pasteur and Pierre Paul Émile Roux created the first rabies vaccine. The first diphtheria vaccines were produced in 1914 from a mixture of diphtheria toxin and antitoxin (produced from the serum of an inoculated animal), but the safety of the inoculation was marginal and it was not widely used. The United States recorded 206,000 cases of diphtheria in 1921 resulting in 15,520 deaths. In 1923 parallel efforts by Gaston Ramon at the Pasteur Institute and Alexander Glenny at the Wellcome Research Laboratories (later part of GlaxoSmithKline) led to the discovery that a safer vaccine could be produced by treating diphtheria toxin with formaldehyde. In 1944, Maurice Hilleman of Squibb Pharmaceuticals developed the first vaccine against Japanese encephelitis. Hilleman would later move to Merck where he would play a key role in the development of vaccines against measles, mumps, chickenpox, rubella, hepatitis A, hepatitis B, and meningitis.


How many cases of Diphtheria were there in 1921?


In 1923, what was discovered to be safer to treat Diphtheria Toxin?


Who created a vaccine to treat Japanese Encephalitis?


How many deaths occurred due to Diphtheria?


The rabies vaccine was created in what year?


In what year was the diphtheria vaccine made?


What compound made the diphtheria vaccine safer to use?


Who developed the first encephalitis vaccine?


What company did Hilleman later work for?


Who manufactured "Elixir Sulfanilamide"?

In 1937 over 100 people died after ingesting "Elixir Sulfanilamide" manufactured by S.E. Massengill Company of Tennessee. The product was formulated in diethylene glycol, a highly toxic solvent that is now widely used as antifreeze. Under the laws extant at that time, prosecution of the manufacturer was possible only under the technicality that the product had been called an "elixir", which literally implied a solution in ethanol. In response to this episode, the U.S. Congress passed the Federal Food, Drug, and Cosmetic Act of 1938, which for the first time required pre-market demonstration of safety before a drug could be sold, and explicitly prohibited false therapeutic claims.


What was one of the things the Federal Food, Drug and Cosmetic Act do?


What year did Congress pass the Federal Food, Drug, and Cosmetic Act?


What is Diethylene Glycol commonly used for now?


What company manufactured Elixir Sulfanilamide?


What drug killed over 100 people in 1937?


Diethylene glycol is mainly used today as what liquid?


What law did Congress pass following the Elixir Sulfanilamide incident?


The name "elixir" implied a solution in what liquid?


When was the first effective treatment for Tuberculosis discovered?

The aftermath of World War II saw an explosion in the discovery of new classes of antibacterial drugs including the cephalosporins (developed by Eli Lilly based on the seminal work of Giuseppe Brotzu and Edward Abraham), streptomycin (discovered during a Merck-funded research program in Selman Waksman's laboratory), the tetracyclines (discovered at Lederle Laboratories, now a part of Pfizer), erythromycin (discovered at Eli Lilly and Co.) and their extension to an increasingly wide range of bacterial pathogens. Streptomycin, discovered during a Merck-funded research program in Selman Waksman's laboratory at Rutgers in 1943, became the first effective treatment for tuberculosis. At the time of its discovery, sanitoriums for the isolation of tuberculosis-infected people were an ubiquitous feature of cities in developed countries, with 50% dying within 5 years of admission.


50% of tuberculosis-infected people died within 5 years where?


What drug effectively treated Tuberculosis?


What was the first treatment for tuberculosis?


What percentage of patients infected with tuberculosis died within 5 years?


In what year was streptomycin discovered?


Many more antibiotics were made following the end of what war?


What company funded the research that led to the discovery of streptomycin?


During the years 1940-1955, the rate of decline in the U.S. death rate accelerated from 2% per year to 8% per year, then returned to the historical rate of 2% per year. The dramatic decline in the immediate post-war years has been attributed to the rapid development of new treatments and vaccines for infectious disease that occurred during these years. Vaccine development continued to accelerate, with the most notable achievement of the period being Jonas Salk's 1954 development of the polio vaccine under the funding of the non-profit National Foundation for Infantile Paralysis. The vaccine process was never patented, but was instead given to pharmaceutical companies to manufacture as a low-cost generic. In 1960 Maurice Hilleman of Merck Sharp & Dohme identified the SV40 virus, which was later shown to cause tumors in many mammalian species. It was later determined that SV40 was present as a contaminant in polio vaccine lots that had been administered to 90% of the children in the United States. The contamination appears to have originated both in the original cell stock and in monkey tissue used for production. In 2004 the United States Cancer Institute announced that it had concluded that SV40 is not associated with cancer in people.


Who announced that SV40 was not associated with cancer?


What was a complication of the SV40 virus?


In what year was the polio vaccine created?


What virus caused tumors in most mammals?


How much was the settlement GlaxoSmithKline agree to?

On 2 July 2012, GlaxoSmithKline pleaded guilty to criminal charges and agreed to a $3 billion settlement of the largest health-care fraud case in the U.S. and the largest payment by a drug company. The settlement is related to the company's illegal promotion of prescription drugs, its failure to report safety data, bribing doctors, and promoting medicines for uses for which they were not licensed. The drugs involved were Paxil, Wellbutrin, Advair, Lamictal, and Zofran for off-label, non-covered uses. Those and the drugs Imitrex, Lotronex, Flovent, and Valtrex were involved in the kickback scheme.


What was one of the causes of the health-care fraud case?


What drugs were related to a kickback scheme?


What drugs were used for off-label uses?


In what year did GlaxoSmithKline pay a $3 billion dollar settlement?


How much was the largest healthcare fraud case in the US settled for?


What company was sued for promoting medicines for unlicensed uses and bribing doctors?


What is the speculation of the relationship between doctors and the drug industry?

In the US, starting in 2013, under the Physician Financial Transparency Reports (part of the Sunshine Act), the Centers for Medicare & Medicaid Services has to collect information from applicable manufacturers and group purchasing organizations in order to report information about their financial relationships with physicians and hospitals. Data are made public in the Centers for Medicare & Medicaid Services website. The expectation is that relationship between doctors and Pharmaceutical industry will become fully transparent.


What is the Physician Financial Transparency Report part of?


Where can you obtain information about the Sunshine Act?


What information is collected by Centers for Medicine & Medicaid Services?


When did Centers for Medicine & Medicaid Services have to start collecting information?


The Physician Financial Transparency Reports was part of what other act?


In what year were Medicaid and Medicare required to disclose information about their relationships with doctors and hospitals?


Where can financial relationships between Medicaid, Medicare and pharmaceutical companies be found?


What is expected when the relationships are made public?


What disease had the biggest decline of deaths?

A Federal Trade Commission report issued in 1958 attempted to quantify the effect of antibiotic development on American public health. The report found that over the period 1946-1955, there was a 42% drop in the incidence of diseases for which antibiotics were effective and only a 20% drop in those for which antibiotics were not effective. The report concluded that "it appears that the use of antibiotics, early diagnosis, and other factors have limited the epidemic spread and thus the number of these diseases which have occurred". The study further examined mortality rates for eight common diseases for which antibiotics offered effective therapy (syphilis, tuberculosis, dysentery, scarlet fever, whooping cough, meningococcal infections, and pneumonia), and found a 56% decline over the same period. Notable among these was a 75% decline in deaths due to tuberculosis.


What was responsible for the decline in spreading diseases?


What period was the report issued in 1958 cover?


How much did the mortality rate of common bacterial infections decline between 1946-1955?


How much did the mortality rate of tuberculosis drop between 1946-1955?


Who issued a report describing the effects of antibiotic developments?


In what year was the FTC's report issued?


How much did treatment for each patient in Africa cost?

In March 2001, 40 multi-national pharmaceutical companies brought litigation against South Africa for its Medicines Act, which allowed the generic production of antiretroviral drugs (ARVs) for treating HIV, despite the fact that these drugs were on-patent. HIV was and is an epidemic in South Africa, and ARVs at the time cost between 10,000 and 15,000 USD per patient per year. This was unaffordable for most South African citizens, and so the South African government committed to providing ARVs at prices closer to what people could afford. To do so, they would need to ignore the patents on drugs and produce generics within the country (using a compulsory license), or import them from abroad. After international protest in favour of public health rights (including the collection of 250,000 signatures by MSF), the governments of several developed countries (including The Netherlands, Germany, France, and later the US) backed the South African government, and the case was dropped in April of that year.


Who backed the South African government which caused the case to be dropped?


How many signatures were collected by MSF?


When was litigation brought to South Africa?


How many companies sued South Africa for its Medicines Act?


South Africa's Medicines Act allowed for the generic production of what kind of drugs?


How much did ARV drugs cost patients yearly?


How many signatures were collected supporting public health rights?


Prior to the 20th century drugs were generally produced by small scale manufacturers with little regulatory control over manufacturing or claims of safety and efficacy. To the extent that such laws did exist, enforcement was lax. In the United States, increased regulation of vaccines and other biological drugs was spurred by tetanus outbreaks and deaths caused by the distribution of contaminated smallpox vaccine and diphtheria antitoxin. The Biologics Control Act of 1902 required that federal government grant premarket approval for every biological drug and for the process and facility producing such drugs. This was followed in 1906 by the Pure Food and Drugs Act, which forbade the interstate distribution of adulterated or misbranded foods and drugs. A drug was considered misbranded if it contained alcohol, morphine, opium, cocaine, or any of several other potentially dangerous or addictive drugs, and if its label failed to indicate the quantity or proportion of such drugs. The government's attempts to use the law to prosecute manufacturers for making unsupported claims of efficacy were undercut by a Supreme Court ruling restricting the federal government's enforcement powers to cases of incorrect specification of the drug's ingredients.


What act allowed premarket approval for drugs?


When did the Pure Food and Drugs Act get implemented?


Who restricted the federal government's enforcement powers?


What was the name of the law that required premarket approval for producing drugs?


What law banned the interstate distribution of mislabeled food and drugs?


In what year was the Pure Food and Drugs Act passed?


Patents have been criticized in the developing world, as they are thought to reduce access to existing medicines. Reconciling patents and universal access to medicine would require an efficient international policy of price discrimination. Moreover, under the TRIPS agreement of the World Trade Organization, countries must allow pharmaceutical products to be patented. In 2001, the WTO adopted the Doha Declaration, which indicates that the TRIPS agreement should be read with the goals of public health in mind, and allows some methods for circumventing pharmaceutical monopolies: via compulsory licensing or parallel imports, even before patent expiration.


What did the TRIPS agreement accomplish?


What has been accused of reducing access to medicines in developing countries?


The Doha Declaration allows for what ways for monopolies to be bypassed?


When did the World Trade Organization adopt the Doha Declaration?


How much money was recovered through the False Claims?

Pharmaceutical fraud involves deceptions which bring financial gain to a pharmaceutical company. It affects individuals and public and private insurers. There are several different schemes used to defraud the health care system which are particular to the pharmaceutical industry. These include: Good Manufacturing Practice (GMP) Violations, Off Label Marketing, Best Price Fraud, CME Fraud, Medicaid Price Reporting, and Manufactured Compound Drugs. Of this amount $2.5 billion was recovered through False Claims Act cases in FY 2010. Examples of fraud cases include the GlaxoSmithKline $3 billion settlement, Pfizer $2.3 billion settlement and Merck & Co. $650 million settlement. Damages from fraud can be recovered by use of the False Claims Act, most commonly under the qui tam provisions which rewards an individual for being a "whistleblower", or relator (law).


What are some of the schemes used to defraud the health care system?


Who had the biggest fraud case settlement?


What provision rewards "whistle-blowers"?


What kind of fraud financially benefits a drug company?


Who is affected by pharmaceutical fraud?


How much money lost to pharmaceutical fraud was recovered in 2010?


Which act allows whistleblowers to recover money lost from pharmaceutical fraud?


What drugs reduce the risk of death and other events in people with high blood pressure?

A 2009 Cochrane review concluded that thiazide antihypertensive drugs reduce the risk of death (RR 0.89), stroke (RR 0.63), coronary heart disease (RR 0.84), and cardiovascular events (RR 0.70) in people with high blood pressure. In the ensuring years other classes of antihypertensive drug were developed and found wide acceptance in combination therapy, including loop diuretics (Lasix/furosemide, Hoechst Pharmaceuticals, 1963), beta blockers (ICI Pharmaceuticals, 1964) ACE inhibitors, and angiotensin receptor blockers. ACE inhibitors reduce the risk of new onset kidney disease [RR 0.71] and death [RR 0.84] in diabetic patients, irrespective of whether they have hypertension.


Who conducted the review on Thiazide Antihypertensive drugs?


What were Thiazide Antihypertensive drugs used with?


In what year did Cochrane release the report?


What reduces the risk of new onset kidney diseases and death?


What type of drugs reduced the risk of strokes and heart disease for people with high blood pressure?


In what year was thiazide antihypertensive drugs shown to help those with heart problems?


Others have argued that excessive regulation suppresses therapeutic innovation, and that the current cost of regulator-required clinical trials prevents the full exploitation of new genetic and biological knowledge for the treatment of human disease. A 2012 report by the President's Council of Advisors on Science and Technology made several key recommendations to reduce regulatory burdens to new drug development, including 1) expanding the FDA's use of accelerated approval processes, 2) creating an expedited approval pathway for drugs intended for use in narrowly defined populations, and 3) undertaking pilot projects designed to evaluate the feasibility of a new, adaptive drug approval process.


What has been argued restricted innovation?


What was a recommendations brought about from the report?


What is one thing excessive regulations causes?


What can be used to evaluate new approval processes?


What is excessive drug regulation said to suppress?


In what year was a report made to reduce the burdens of drug development?


What was argued to be holding back new knowledge for treating diseases?


In 1952 researchers at Ciba discovered the first orally available vasodilator, hydralazine. A major shortcoming of hydralazine monotherapy was that it lost its effectiveness over time (tachyphylaxis). In the mid-1950s Karl H. Beyer, James M. Sprague, John E. Baer, and Frederick C. Novello of Merck and Co. discovered and developed chlorothiazide, which remains the most widely used antihypertensive drug today. This development was associated with a substantial decline in the mortality rate among people with hypertension. The inventors were recognized by a Public Health Lasker Award in 1975 for "the saving of untold thousands of lives and the alleviation of the suffering of millions of victims of hypertension".


Why were the researchers recognized in 1975?


What was the main shortcoming in the drug Hydralazine?


What was the name of the first oral vasodilator?


What is the most used antihypertensive drug today?


Beyer, Sprague, Baer, and Novello received what award in 1975?


In what year was hydralazine discovered?


Chlorothiazide helped reduce the mortality rate among those with what disease?


In the U.S., a push for revisions of the FD&C Act emerged from Congressional hearings led by Senator Estes Kefauver of Tennessee in 1959. The hearings covered a wide range of policy issues, including advertising abuses, questionable efficacy of drugs, and the need for greater regulation of the industry. While momentum for new legislation temporarily flagged under extended debate, a new tragedy emerged that underscored the need for more comprehensive regulation and provided the driving force for the passage of new laws.


What were the major issues that needed to be addressed?


Congressional hearings emerged addressing revisions to what act?


Who led the Congressional hearings in 1959?


Did the US Congress call for more or less regulation of pharmaceuticals?


What did the first measles prevent in it's first 20 years?

Other notable new vaccines of the period include those for measles (1962, John Franklin Enders of Children's Medical Center Boston, later refined by Maurice Hilleman at Merck), Rubella (1969, Hilleman, Merck) and mumps (1967, Hilleman, Merck) The United States incidences of rubella, congenital rubella syndrome, measles, and mumps all fell by >95% in the immediate aftermath of widespread vaccination. The first 20 years of licensed measles vaccination in the U.S. prevented an estimated 52 million cases of the disease, 17,400 cases of mental retardation, and 5,200 deaths.


Who originally created the measles vaccine?


How much did the occurrence of serious diseases shortly after the release of the measles vaccine?


In what year was the measles vaccine made?


In what year was the mumps vaccine made?


How much did rubella, measles, and mumps infections drop after vaccination?


Measles vaccinations helped prevent how many estimated cases of the illness?


When did the Kefauver-Harris Amendment become a law?

The thalidomide tragedy resurrected Kefauver's bill to enhance drug regulation that had stalled in Congress, and the Kefauver-Harris Amendment became law on 10 October 1962. Manufacturers henceforth had to prove to FDA that their drugs were effective as well as safe before they could go on the US market. The FDA received authority to regulate advertising of prescription drugs and to establish good manufacturing practices. The law required that all drugs introduced between 1938 and 1962 had to be effective. An FDA - National Academy of Sciences collaborative study showed that nearly 40 percent of these products were not effective. A similarly comprehensive study of over-the-counter products began ten years later.


What did the National Academy of Science's study discover?


How long after the National Academy of Science's study did a study on over the counter drugs occur?


What brought up enhancement of drug regulations?


When did the Kefauver-Harris Amendment became law?


What federal agency regulated the advertising of prescription drugs?


Drugs made between which years had to be tested before going to market?


What percentage of drugs were shown to be ineffective after an FDA study?


How many Americans were given the drug Kevadon?

The firm continued to pressure Kelsey and the agency to approve the application—until November 1961, when the drug was pulled off the German market because of its association with grave congenital abnormalities. Several thousand newborns in Europe and elsewhere suffered the teratogenic effects of thalidomide. Though the drug was never approved in the USA, the firm distributed Kevadon to over 1,000 physicians there under the guise of investigational use. Over 20,000 Americans received thalidomide in this "study," including 624 pregnant patients, and about 17 known newborns suffered the effects of the drug.[citation needed]


When was the drug taken off shelves in Germany?


How many newborns were born with issues due to Kevadon?


In what year was thalidomide banned in Germany?


What adverse effect was thalidomide associated with?


Thalidomide was distributed in the USA by what name?


About how many Americans received thalidomide in a supposed study?


How many newborn American babies were affected by thalidomide?


Prior to the second world war, birth control was prohibited in many countries, and in the United States even the discussion of contraceptive methods sometimes led to prosecution under Comstock laws. The history of the development of oral contraceptives is thus closely tied to the birth control movement and the efforts of activists Margaret Sanger, Mary Dennett, and Emma Goldman. Based on fundamental research performed by Gregory Pincus and synthetic methods for progesterone developed by Carl Djerassi at Syntex and by Frank Colton at G.D. Searle & Co., the first oral contraceptive, Enovid, was developed by E.D. Searle and Co. and approved by the FDA in 1960. The original formulation incorporated vastly excessive doses of hormones, and caused severe side effects. Nonetheless, by 1962, 1.2 million American women were on the pill, and by 1965 the number had increased to 6.5 million. The availability of a convenient form of temporary contraceptive led to dramatic changes in social mores including expanding the range of lifestyle options available to women, reducing the reliance of women on men for contraceptive practice, encouraging the delay of marriage, and increasing pre-marital co-habitation.


What increased due to the availability of birth control?


Who created the first oral birth control?


In 1965, how many women were on the birth control pill?


Discussing contraception sometimes led to prosecution under what laws?


What was the name of the first oral contraceptive?


By 1965, about how many American women were taking Enovid?


Birth control was prohibited in most countries before what war?


Who received the Laser-Debakey Clinical Medical Research Aware?

In April 1994, the results of a Merck-sponsored study, the Scandinavian Simvastatin Survival Study, were announced. Researchers tested simvastatin, later sold by Merck as Zocor, on 4,444 patients with high cholesterol and heart disease. After five years, the study concluded the patients saw a 35% reduction in their cholesterol, and their chances of dying of a heart attack were reduced by 42%. In 1995, Zocor and Mevacor both made Merck over US$1 billion. Endo was awarded the 2006 Japan Prize, and the Lasker-DeBakey Clinical Medical Research Award in 2008. For his "pioneering research into a new class of molecules" for "lowering cholesterol,"[sentence fragment]


What did the study reveal after 5 years?


Patients treated with Zocor had their cholesterol reduced by how much?


How much did Zocor reduce the chance of dying from a heart attack?


How much money did Merck make from sales of Zocor and Mevacor?


Drug discovery is the process by which potential drugs are discovered or designed. In the past most drugs have been discovered either by isolating the active ingredient from traditional remedies or by serendipitous discovery. Modern biotechnology often focuses on understanding the metabolic pathways related to a disease state or pathogen, and manipulating these pathways using molecular biology or biochemistry. A great deal of early-stage drug discovery has traditionally been carried out by universities and research institutions.


Who is usually responsible for early stages of drug discovery?


What is the name of the process in which possible drugs are discovered?


What groups carry out most early drug discoveries?


What kind of technology studies the understanding and manipulation of disease states and pathogens?


Most drugs have been found by isolating what from traditional remedies?


How much does it cost to develop a new drug?

Drug discovery and development is very expensive; of all compounds investigated for use in humans only a small fraction are eventually approved in most nations by government appointed medical institutions or boards, who have to approve new drugs before they can be marketed in those countries. In 2010 18 NMEs (New Molecular Entities) were approved and three biologics by the FDA, or 21 in total, which is down from 26 in 2009 and 24 in 2008. On the other hand, there were only 18 approvals in total in 2007 and 22 back in 2006. Since 2001, the Center for Drug Evaluation and Research has averaged 22.9 approvals a year. This approval comes only after heavy investment in pre-clinical development and clinical trials, as well as a commitment to ongoing safety monitoring. Drugs which fail part-way through this process often incur large costs, while generating no revenue in return. If the cost of these failed drugs is taken into account, the cost of developing a successful new drug (new chemical entity, or NCE), has been estimated at about 1.3 billion USD(not including marketing expenses). Professors Light and Lexchin reported in 2012, however, that the rate of approval for new drugs has been a relatively stable average rate of 15 to 25 for decades.


How many approvals of new drugs happen every year?


Who is responsible for approval or rejection of new drugs?


Who reported the stable average rate in 2012?


How many pharmaceutical drugs were approved on average since 2001?


What is the approximate cost of developing a new drug, including the costs of failure?


What has been the stable approval rate of new drugs?


What drugs are the least expensive to develop?

Some of these estimates also take into account the opportunity cost of investing capital many years before revenues are realized (see Time-value of money). Because of the very long time needed for discovery, development, and approval of pharmaceuticals, these costs can accumulate to nearly half the total expense. A direct consequence within the pharmaceutical industry value chain is that major pharmaceutical multinationals tend to increasingly outsource risks related to fundamental research, which somewhat reshapes the industry ecosystem with biotechnology companies playing an increasingly important role, and overall strategies being redefined accordingly. Some approved drugs, such as those based on re-formulation of an existing active ingredient (also referred to as Line-extensions) are much less expensive to develop.


What accounts for nearly half of the costs to develop drugs?


What is the consequence in the value chain?


What is re-formulations of active ingredients referred to?


Investing capital can increase drug development costs by how much?


What kind of companies have had a more important role in drug development?


What firms tend to outsource drug development?


In 1971, Akira Endo, a Japanese biochemist working for the pharmaceutical company Sankyo, identified mevastatin (ML-236B), a molecule produced by the fungus Penicillium citrinum, as an inhibitor of HMG-CoA reductase, a critical enzyme used by the body to produce cholesterol. Animal trials showed very good inhibitory effect as in clinical trials, however a long term study in dogs found toxic effects at higher doses and as a result mevastatin was believed to be too toxic for human use. Mevastatin was never marketed, because of its adverse effects of tumors, muscle deterioration, and sometimes death in laboratory dogs.


What is HMG-CoA responsible for producing?


What was discovered in long term studies?


How much did Pfizer settle the illegal marketing suit for?

Every major company selling the antipsychotics — Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca and Johnson & Johnson — has either settled recent government cases, under the False Claims Act, for hundreds of millions of dollars or is currently under investigation for possible health care fraud. Following charges of illegal marketing, two of the settlements set records last year for the largest criminal fines ever imposed on corporations. One involved Eli Lilly's antipsychotic Zyprexa, and the other involved Bextra. In the Bextra case, the government also charged Pfizer with illegally marketing another antipsychotic, Geodon; Pfizer settled that part of the claim for $301 million, without admitting any wrongdoing.


What drugs were involved in cases of the largest criminal fines?


What was Pfizer accused of illegally marketing?


What companies have been involved with health care fraud cases?


What do illegal marketing cases fall under?


Firms such as Eli Lilly, Pfizer, and AstraZeneca have settled claims under what act?


Pfizer was charged with illegally marketing what antipsychotic drug?


Pfizer settled the Geodon lawsuit for how much money?


Who were some of the companies that encouraged the interactions between doctors and the pharmaceutical industry?

In contrast to this viewpoint, an article and associated editorial in the New England Journal of Medicine in May 2015 emphasized the importance of pharmaceutical industry-physician interactions for the development of novel treatments, and argued that moral outrage over industry malfeasance had unjustifiably led many to overemphasize the problems created by financial conflicts of interest. The article noted that major healthcare organizations such as National Center for Advancing Translational Sciences of the National Institutes of Health, the President’s Council of Advisors on Science and Technology, the World Economic Forum, the Gates Foundation, the Wellcome Trust, and the Food and Drug Administration had encouraged greater interactions between physicians and industry in order to bring greater benefits to patients.


When did the article come out about the importance of interactions?


What was the reason behind these interactions?


What was believed to have created a financial conflict of interest?


Who printed the article about the importance of interactions?


What publication had an article about the importance of pharmaceutical industry-physician interactions in 2015?


Did major healthcare organizations support or discourage interactions between doctors and industries?


Who conduced an investigation on doctors?

An investigation by ProPublica found that at least 21 doctors have been paid more than $500,000 for speeches and consulting by drugs manufacturers since 2009, with half of the top earners working in psychiatry, and about $2 billion in total paid to doctors for such services. AstraZeneca, Johnson & Johnson and Eli Lilly have paid billions of dollars in federal settlements over allegations that they paid doctors to promote drugs for unapproved uses. Some prominent medical schools have since tightened rules on faculty acceptance of such payments by drug companies.


Billions of dollars have been paid by which companies?


How much was discovered to have been paid to doctors by drug companies?


What was the reason these companies have to pay fines?


How many doctors have been paid by varies companies?


A ProPublica study found that some doctors were being paid how much money for speeches?


Half of the top earners were mostly in what field?


Drug manufacturers paid off doctors a total of how much money?


Why are collaborative agreements important?

Often, large multinational corporations exhibit vertical integration, participating in a broad range of drug discovery and development, manufacturing and quality control, marketing, sales, and distribution. Smaller organizations, on the other hand, often focus on a specific aspect such as discovering drug candidates or developing formulations. Often, collaborative agreements between research organizations and large pharmaceutical companies are formed to explore the potential of new drug substances. More recently, multi-nationals are increasingly relying on contract research organizations to manage drug development.


How do large corporations show vertical integration?


What are large companies relying on outside organizations for?


What are smaller organizations responsible for?


What type of integration do large corporations often do?


What type of integration do smaller organizations do?


What type of agreements are made to research potential new drugs?


What type of organizations are multinational corporations increasingly rely on?


In the UK, the Medicines and Healthcare Products Regulatory Agency approves drugs for use, though the evaluation is done by the European Medicines Agency, an agency of the European Union based in London. Normally an approval in the UK and other European countries comes later than one in the USA. Then it is the National Institute for Health and Care Excellence (NICE), for England and Wales, who decides if and how the National Health Service (NHS) will allow (in the sense of paying for) their use. The British National Formulary is the core guide for pharmacists and clinicians.


Who is responsible for approving drugs in the United Kingdom?


After an approval in the United States, when does an approval occur in the United Kingdom and other countries?


Who does the evaluations for drugs in the United Kingdom?


What UK firm approves pharmaceutical drugs?


What firm in England and Wales decides if the NHS allows drugs?


What is the name of the core guide for pharmacists and clinicians?


There are special rules for certain rare diseases ("orphan diseases") in several major drug regulatory territories. For example, diseases involving fewer than 200,000 patients in the United States, or larger populations in certain circumstances are subject to the Orphan Drug Act. Because medical research and development of drugs to treat such diseases is financially disadvantageous, companies that do so are rewarded with tax reductions, fee waivers, and market exclusivity on that drug for a limited time (seven years), regardless of whether the drug is protected by patents.


What is given to companies who develop drugs for "orphan diseases"?


What size of disease populations are subject to the Orphan Drug Act?


What is one financial benefit to researching orphan drugs?


What is the length of time of market exclusivity of an orphan drug?


What is a term for rare diseases in some territories?


Ben Goldacre has argued that regulators – such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, or the Food and Drug Administration (FDA) in the United States – advance the interests of the drug companies rather than the interests of the public due to revolving door exchange of employees between the regulator and the companies and friendships develop between regulator and company employees. He argues that regulators do not require that new drugs offer an improvement over what is already available, or even that they be particularly effective.


Who argued that drug regulators were greater serving the interests of the drug companies than the patients?


The business friendships between which parties have been criticized?


Goldacre argued that which party didn't require that new drugs be improved at all?


NICE decides the availability of drugs in which two countries?

In many non-US western countries a 'fourth hurdle' of cost effectiveness analysis has developed before new technologies can be provided. This focuses on the efficiency (in terms of the cost per QALY) of the technologies in question rather than their efficacy. In England and Wales NICE decides whether and in what circumstances drugs and technologies will be made available by the NHS, whilst similar arrangements exist with the Scottish Medicines Consortium in Scotland, and the Pharmaceutical Benefits Advisory Committee in Australia. A product must pass the threshold for cost-effectiveness if it is to be approved. Treatments must represent 'value for money' and a net benefit to society.


What is the name of the organization in Scotland that decides the availability of drugs?


What threshold must a drug pass before it is approved?


How much money did the top ten bestselling drugs make in 2013?

The top ten best-selling drugs of 2013 totaled $75.6 billion in sales, with the anti-inflammatory drug Humira being the best-selling drug worldwide at $10.7 billion in sales. The second and third best selling were Enbrel and Remicade, respectively. The top three best-selling drugs in the United States in 2013 were Abilify ($6.3 billion,) Nexium ($6 billion) and Humira ($5.4 billion). The best-selling drug ever, Lipitor, averaged $13 billion annually and netted $141 billion total over its lifetime before Pfizer's patent expired in November 2011.


What was the name of the top-selling anti-inflammatory drug in 2013?


What was the bestselling drug in history?


How much money did Lipitor make before the patent expired?


In what year did Pfizer's patent over Lipitor expire?


How long do drug exclusivity rights usually last?

Depending on a number of considerations, a company may apply for and be granted a patent for the drug, or the process of producing the drug, granting exclusivity rights typically for about 20 years. However, only after rigorous study and testing, which takes 10 to 15 years on average, will governmental authorities grant permission for the company to market and sell the drug. Patent protection enables the owner of the patent to recover the costs of research and development through high profit margins for the branded drug. When the patent protection for the drug expires, a generic drug is usually developed and sold by a competing company. The development and approval of generics is less expensive, allowing them to be sold at a lower price. Often the owner of the branded drug will introduce a generic version before the patent expires in order to get a head start in the generic market. Restructuring has therefore become routine, driven by the patent expiration of products launched during the industry's "golden era" in the 1990s and companies' failure to develop sufficient new blockbuster products to replace lost revenues.


Governments grant permission to market drugs after how many years?


What enables a drug's owner to recover R&D costs?


What kind of drug is produced by competitors once a patent expires?


What decade was the pharmaceutical industry's "golden era"?


The safety and efficacy of new drugs must be approved by what organization in the US?

In the United States, new pharmaceutical products must be approved by the Food and Drug Administration (FDA) as being both safe and effective. This process generally involves submission of an Investigational New Drug filing with sufficient pre-clinical data to support proceeding with human trials. Following IND approval, three phases of progressively larger human clinical trials may be conducted. Phase I generally studies toxicity using healthy volunteers. Phase II can include pharmacokinetics and dosing in patients, and Phase III is a very large study of efficacy in the intended patient population. Following the successful completion of phase III testing, a New Drug Application is submitted to the FDA. The FDA review the data and if the product is seen as having a positive benefit-risk assessment, approval to market the product in the US is granted.


What type of filing is used before beginning human trials?


How many phases of human trials may be done after IND approval?


What type of application is filed after completing three phases of human trials?


What type of risk assessment results in approving the drug to go on the market?