The Food and Drug Administration (FDA) is the federal agency responsible for the approval, regulation, and control of prescription medications. All prescription medications must complete an extensive FDA approval process, which can take years. In an attempt to expedite this process, Congress passed the Biologics Price Competition and Innovation Act in 2009, which created a faster approval pathway for biologic products that are highly similar to existing FDA-approved medications. The law applies only to biologic products, those produced with living organisms, but not to chemically produced drugs. Insulin is a vital prescription medication used to treat diabetes. Over an eight-year period, beginning in 2009, the average price of insulin increased from $90 to $275 a vial. Since insulin was not regulated as a biologic, the time necessary to gain FDA approval prevented new companies from developing less expensive alternatives.

In 2017, public attention to the rising cost of insulin led the FDA to reclassify the drug as a biologic, thereby lessening the amount of time it took for new companies to get FDA approval. With more manufacturers competing in the marketplace, prices would likely drop.


After reading the scenario, respond to A, B, and C below.

A. Referencing the scenario, describe the executive branch authority used by the FDA in reclassifying insulin as a biologic and explain how this use of the FDA’s authority might affect the success of the Biologics Price Competition and Innovation Act.

B. Referencing the scenario, explain how Congress could have addressed the increasing cost of insulin prior to 2017.

C. Describe an informal power the president could use to influence the FDA’s decision to reclassify insulin as a biologic. Explain how the use of that informal power relates to the principle of separation of powers.

General Sherman's conquest of Atlanta turned the tide of the presidential election of 1864, ensuring that Lincoln would again take office and that armies would continue pressure on the Rebel. So correct answer is True.

A formal process of communal decision-making, an election is how a population choose a person or people to participate in government. Since the 17th century, elections have been the primary method used to carry out representative democracy in contemporary times. Election may be held to fill legislative, occasionally executive, occasionally judicial, and occasionally regional and municipal positions. Numerous other private and commercial organizations, including clubs, nonprofit organizations, and businesses, also employ this procedure. Under the parliamentary government of such Spartan Constitution, the Ephors of Spartan held the first known popular polls of people to public official, by democratic majority, where all people were entitled to vote.

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Individuals who possess adaptive features (traits that provide them an advantage) are more likely to live and reproduce. These people then pass on their adaptive qualities to their descendants. These beneficial features become more widespread in the population over time.

The overall notion of evolution was quickly accepted as a result of debate over Darwin's work, but the specific mechanism he proposed, natural selection, was not widely accepted until it was revitalized by biological advancements from the 1920s to the 1940s.

The term "electronic commerce" refers to the sale of electronic goods. He proposed the theory of natural selection for evolution and demonstrated that all existing species of creatures descended from a common ancestor.

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Answer:

Church expelled a person from its membership and banned that person from taking part in its rites and services.

Explanation:

The Church used the power of excommunication against those persons, including kings and powerful lords, who flagrantly violated Church laws or trampled on its rights. By excommunication the Church expelled a person from its membership and banned that person from taking part in its rites and services.

I would change the flower's petal color to a more vibrant orange hue, rather than its current muted orange shade.

Flowers are one of the most beautiful creations of nature. They come in different shapes, sizes, colors, and fragrances. Some flowers have a single petal while some have many. Some have a unique and special scent while others have none at all. The most common colors of flowers are yellow, pink, red, white, and purple. They also have different meanings depending on the type of flower. For example, roses are associated with love, and lilies are associated with purity or innocence. Flowers can also be used to decorate the home or garden or to create a special bouquet for a loved one. Overall, flowers are a beautiful addition to any home or garden.

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Answer:

Levittowns were suburban communities with mass-produced tract houses built in the 1950s in New York, Pennsylvania, and New Jersey by contractor William Levitt. They were typically inhabited by young white middle-class couples who fled the cities in search of homes to buy for their growing families. SIG: Levitt's homes, priced at $7,990, were beyond the means of young families, so the Federal Housing Administration and Veterans Administrations became major components of home-financing, requiring small down payment for insured mortgages. Levittowns also idealized homogenous communities, where the developments were mostly young married adults who cut their lawns once a week, never put up laundry on the weekends, and did not tolerate neighbors outside of the Protestant Caucasion race.

One way the second Industrial Revolution differed from the first Industrial Revolution as the first revolution brought large numbers of immigrants to American cities. Thus, option 'D' is the correct option.

Textiles, railways, iron, and coal all developed as a result of the first industrial revolution. Steel, electricity, chemicals, and petroleum were used to construct the second. The First Industrial Revolution concentrated on the manufacture of textiles and the invention of the steam engine, but the Second Industrial Revolution was more concerned with the development of steel, the car, and electricity.

Communication technology was enhanced by electrical science discoveries. Ten years after Alexander Graham Bell successfully established the first undersea telegraph line across the Atlantic Ocean in 1866, the telephone was created.

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Answer:

The second was based on farming improvements.

Explanation:

got it right on flvs

Answer: It depends on where (False)

Explanation: It depends on where the people are and how the monarchies treated them. Take the 13 original colonies and Great Britain for example. The 13 colonies in America didn't have to pay as much as the people in Britain had to pay, because then Great Britain didn't have DIRECT control over the colonies and some rebels refused to pay taxes. Though, other monarchies were seen as forcing their people to pay higher taxes. So, no they did not have low taxes. (all the time)

The statements about subjective ideas that are true are:

(B) They cannot be supported with facts.  

(C) They are based on opinions.  

(E) They use only evidence that supports the idea.

Subjective thinking is entirely determined by a person's views, which may or may not correspond to those of other people. Subjective thinking may ignore the truth in order to support one's own beliefs. Subjective thoughts are those that are based on individual opinions or beliefs about a person.

The individual's personal views and preferences have an impact on these notions. Since no fact can substantiate them, they cannot be considered universal truths. They contrast with objective thoughts, which are factual notions that may be demonstrated to be true or wrong. These are not beliefs.

Since they are not universal truths, statements B, C, and E that they are not supported by facts and merely use evidence to support the idea are true.

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Which statements about subjective ideas are true? Check all that apply. They can be proven with facts. They cannot be supported with facts. They are based on opinions. They recognize all relevant evidence of an idea. They use only evidence that supports the idea

One of the reasons of why the Soviet Union was able to withstand the German invasion without completely collapsing is because of the poor strategic planning.

Clearly, Operation Barbarossa was a failure. Despite significant losses and territorial gains by the Red Army, the goal of completely destroying Soviet fighting capability and forcing a capitulation was not met.

Poor strategic planning was one of the main causes of this. The Germans did not have a viable long-term invasion strategy. They erroneously believed that the campaign would be brief and that the Soviets would capitulate after being shocked by colossal initial defeats. Hitler promised the High Command that the "whole rotten structure" would come tumbling down if they simply kicked in the front door. Russia, however, was not France.The initial Blitzkrieg's shock factor was diminished by the immense distances, logistical challenges, and sheer quantity of Soviet troops, all of which led to attritional losses of German forces that could not be sustained. 

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1972 – President Nixon is invited to China and signs the Shanghai Communiqué which enables the two countries to discuss difficult issues such as the sovereignty of Taiwan.

Three things that the prophets of the Old Testament did as part of their ministry to the Jewish people in both the northern and southern kingdoms were: encouraged the people, exhorted the people, and warned the people.

Old Testament was the first division of the Christian biblical canon. It consists of 24 books that are the collection of Hebrew writings by the Israelites. It talks about the creation of Earth through Noah and the flood, Moses and more.

Jewish were the people that originated from Israel and Hebrew. They were a group of ethnoreligious people. They believe that there is only one God who communicated with its believers through the prophets.

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The thing that millers quote about his actions reveal about him is when mass hysteria takes hold in society, it's necessary for people to step up to the plate and do the right thing.

Mass hysteria  serves as the outbreak of unusual and uncharacteristic behaviors, thoughts as well as feelings, or health symptoms shared among a group of people.

In some cases People that are affected by mass hysteria usually have this belief that something specific has triggered their symptoms however Hysteria  could take place in two types we have the Primary Hysteria which do take place due to substantial personality disorder, then we also have Secondary Hysteria that can be seen as a result of the  underlying mental health disorders like anxiety and depression.

Hence , when mass hysteria takes hold in society, it's necessary for people to step up to the plate and do the right thing.

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Kapauku ceremonial life is secular and individualistic with pig feast as the most elaborate ceremony.

Kapauku refers to the group of people that reside at the Wissel Lakes area of Central Papua, Indonesia. They are also known by other names like Bunani Mee, Ekari or Ekagi. The language that these people speak is called Ekagi.

Ceremony can be defined as the celebration of any event that may be religious or a normal public event. The pig feast in Kapauku is a very celebrated event and is also called "juwo". It is a series of rituals where the pigs are slaughtered and the pork is then distributed by the sponsors.

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The government campaigns aim to shape public opinion positively, individuals may have diverse beliefs and attitudes towards income tax based on their values, experiences, and perceptions of government practices.

The government has used various methods to influence citizens' views of paying income tax over the years.

One common approach is to highlight the importance of taxes in funding essential public services and government programs.

They may emphasize how tax revenues support education, healthcare, infrastructure development, and social welfare initiatives.

By framing income tax as a means of contributing to the greater good and the well-being of society, the government aims to garner support and acceptance from citizens.

Another strategy is to promote a sense of civic duty and patriotism. Government campaigns may appeal to citizens' sense of responsibility as contributing members of society, urging them to pay their fair share to support the nation's progress and prosperity.

Such campaigns may highlight the sacrifices made by past generations and the role of taxes in upholding democratic values and the country's stability.

The government also utilizes communication channels and public relations efforts to disseminate information about tax benefits and incentives.

Tax credits, deductions, and exemptions may be promoted to show how citizens can reduce their tax burden legally and gain financial advantages.

Whether these strategies would work for an individual depends on various factors.

Some citizens may be more receptive to the idea of paying taxes as a civic duty and contributing to the greater good, while others might be motivated by the potential benefits and incentives offered.

Personal financial situations, perceptions of government transparency and efficiency, and trust in the government's use of tax revenues can also influence one's views on income tax.

Ultimately, the effectiveness of these approaches varies from person to person.

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Answer:

False

Explanation:

Notre Dame is not the first great cathedral to incorporate flying buttresses. The use of flying buttresses in architecture dates back to the 12th century, and they were commonly used in Gothic cathedrals such as Chartres, Reims, and Amiens. Notre Dame, which was built in the 12th and 13th centuries, is considered a masterpiece of Gothic architecture and incorporates flying buttresses, but it is not the first great cathedral to do so.

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The Match of the terms on the left with their definitions  are:

A. Kiva- a round room dug into the ground where Anasazi gathered to make laws, discuss problems, and hold religious ceremonies

B. Totem pole- animal and human figures carved from fir trees and painted; a symbol of a Northwest Indian family’s power and rank

C. Anasazi- a term meaning “ancient enemies,” used by Navaho Indians to describe another tribe of Native Americans who lived in the American Southwest

D. Igloo- a domed house made of snow bricks with ice windows

E. Inuit- a term meaning “the people,” used by the people who live in the far north of North America to describe themselves

F. Potlatch- a party with much feasting that has been planned for years, and ends with the host giving away his finest possessions

Tribes of Indians from the Northwest Coast, including the Tlingit, Haida, and Tsimshian, have a heritage of creating totem poles. The majority of them are made from huge red cedar trees. The oldest totem poles have already perished since totem poles are composed of cedar wood, which decays over time.

Totem pole carvings by Native American Indians were a common way for them to express themselves. Contrary to popular belief, not all Indian tribes carved totem poles. There were no trees available for carving for the Indians who lived in the southwest, the plains, or the Inuit.

Therefore, the Sami of northern Europe and Native Americans are two nearby Indigenous populations from which Inuit can be distinguished biologically and culturally.

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Huey long was one of the following men did not challenge new deal policies.

Robert A. Taft, powerful Republican senator from Ohio from 1939 to 1953. Taft was the leader of the conservative wing of the Republican Party; he consistently denounced the New Deal as "socialism" and argued that it harmed American business interests and gave  the central government in Washington more and more control. Huey Long was the governor of Louisiana.

He was a supporter of Franklin D. Roosevelt, but  not a supporter of his plan, the "New Deal". So Mr. Long cut ties with Roosevelt to create his own plan. Mr. Long felt that the "New Deal" was not enough to cover  the majority of America's poor. His plan called "Sharing our wealth" This plan  on paper would give people the opportunity to travel, get homes and education without expensive expenses.

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Answer:

B. It killed tens of thousands instantly, and tens of thousands more from the blast and fire that followed.

The impact of the atomic bomb on Hiroshima, Japan killed tens of thousands instantly, and tens of thousands more from the blast and fire that followed. Thus, option B is correct.

The term "atomic bomb" typically refers to a device that releases energy by the fission of heavy atoms into lighter ones.

Plenty of survivors started to experience the side effects of having been exposed to radiation. Their signs and symptoms included everything from vomiting, bleeding, and even hair loss to death. Additional risks included eye diseases, aggressive tumors, leukemia susceptibility, and scorching burns.

The stratosphere was breached. Everything within a 30-mile radius of the blast was destroyed, but serious damage was sustained over a 150-mile area, adequate to completely destroy any significant town in modern times, including its suburbs

Therefore, option A is correct.

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The  power of Congress helps form a more perfect union is providing a check for executive power.

Congress is the legislative body created by the United States Constitution. Under the U.S. Constitution, Article 1 establishes the powers of Congress. These include the power to approve financial budgets, tax citizens, reserve funds for the armed forces, declare war, and other additional powers granted to him by the Constitution.

Congress is considered a "power" because it controls the funds provided to the executive branch for proper purposes. As the legislative body, Congress is the primary body responsible for managing powers within the executive and judicial branches of government. Congress will review their power overages and ensure other branches do not abuse them.

Its extensive powers, including control over executive powers, make it a perfect union.

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Answer:

Which of the following was true of New Englanders' westward migration during the 1790s and 1800s? Much of the land in the areas where the settlers arrived had already fallen into the hands of politically well-connected speculators.

Explanation:

The most distinctive feature of the early American cities of Mexico City, Vera Cruz, and Lima is that they were all very large. This city was the heart city of America.

City of Mexico so so special because it stands on the ruins of an ancient Aztec capital city that was built on lake and it was the capital of New Spain and the very oldest and inhabited city in the Americas.There are so many interesting things about Mexico city was  it is the most populated city in the western hemisphere.

Mexico was famous for its rich culture , dazzling beaches and incredible cuisine.180 museums are there in Mexico city  and it has a sprawling public transport system. Mexico was a beautiful city because there are quieters neighborhoods, calmer and absolutely beautiful people.

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Due to industrialization, many industries experienced growth rates of over 50% within a few years during the nineteenth century.

The Industrial Revolution transformed an economy based on agriculture and handicrafts into an economy based on large-scale industry, mechanized manufacturing, and a factory system. New machines, new sources of energy, and new ways of organizing work have increased the productivity and efficiency of existing industries.

The Industrial Revolution caused rapid urbanization in America, with people moving from the countryside to the big cities in droves. In 1800, only 6% of the American population lived in cities, but by 1900 that number had increased to 40%.By 1920, the majority of Americans lived in cities.

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The Bacon's Rebellion was a rebellion against the government and Native Americans by poor people, slaves and servants because the gap between rich and poor was getting bigger, and because their governor would not fight the Native Americans at the frontier of the colonies so people could have more land.

Virginian colonists engaged in an armed uprising known as Bacon's Rebellion between 1676 and 1677. After Governor William Berkeley rejected Nathaniel Bacon's proposal to expel Native Americans from Virginia, Bacon joined the revolt against Berkeley. Virginian colonists engaged in an armed uprising known as Bacon's Rebellion between 1676 and 1677. After Governor William Berkeley rejected Nathaniel Bacon's proposal to expel Native Americans from Virginia, Bacon joined the revolt against Berkeley. The last significant insurrection of black and white indentured servants in Colonial Virginia was during Bacon's Rebellion in 1676. The expansion of African slavery and the social segregation of blacks and whites in Virginia were two effects of the failed uprising.

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The role of the government in a free market is to provide for national defense, address environmental concerns, define and protect property rights, and attempt to make markets more competitive.

A free market is a type of economic system in which the pricing of goods and services are set by the supply and demand indicated by sellers and purchasers. As modeled, such markets operate without the involvement of the government or any other outside authority.

In a free market economy, government has an economic role to play anytime the advantages of a government program outweigh the costs. Governments frequently fund national security, handle environmental issues, establish and preserve property rights, and try to make markets more competitive.

Therefore, In a free market, the government's job is to provide for national security, handle environmental problems, define and enforce property rights, and make markets more competitive.

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The concept and the answers to the given questions are mentioned  below:

Walter Rodney argues that development and underdevelopment are not simply economic terms, but have broad social, political, and cultural implications. He defines development as “the process whereby the productive capacity of a society is increased and its efficiency is improved so that there is a steady rise in the standard of living of the population.” Underdevelopment, in contrast, is the opposite of this; it is “the process whereby the productive capacity of a society is diminished and its efficiency is reduced so that there is a steady fall in the standard of living of the population.”

Rodney argues that the process of development and underdevelopment is not simply a matter of economic productivity, but is inextricably linked to social, political, and cultural factors. He argues that the “unequal distribution of power” is a major factor in the process of development and underdevelopment. He argues that wealthy and powerful countries are able to “exploit” poorer countries and use their resources for their own gain. This unequal power dynamic serves to keep these countries in a state of underdevelopment, as they are unable to use their resources to their own benefit.

Rodney also argues that colonialism has played a major role in the process of development and underdevelopment. He argues that colonialism has been used to “stifle” the development of countries in Africa and other parts of the world. He argues that colonialism has served to limit the ability of these countries to use their resources in a way that would benefit their citizens and instead has caused them to remain in a state of underdevelopment.

Ultimately, Rodney argues that development and underdevelopment are not simply economic terms, but are inextricably linked to social, political, and cultural factors. He argues that the unequal distribution of power, colonialism and other factors have played a major role in keeping countries in a state of underdevelopment.

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Answer:

Explanation:

William Jennings Bryan

Answer:

Explanation:In the decades leading up to the Civil War, the southern states experienced extraordinary change that would define the region and its role in American history for decades, even centuries, to come. Between the 1830s and the beginning of the Civil War in 1861, the American South expanded its wealth and population and became an integral part of an increasingly global economy. It did not, as previous generations of histories have told, sit back on its cultural and social traditions and insulate itself from an expanding system of communication, trade, and production that connected Europe and Asia to the Americas. Quite the opposite; the South actively engaged new technologies and trade routes while also seeking to assimilate and upgrade its most “traditional” and culturally ingrained practices—such as slavery and agricultural production—within a modernizing world.

Answer:

A i think

Explanation:

The United Nations has helped end conflicts and promote reconciliation by conducting successful peacekeeping operations in dozens of countries, including Cambodia.

Many consider the Declaration to be the most important achievement of the United Nations.

Research has found that UN peacebuilding, peacekeeping and conflict prevention work has been a key factor in the 40% decline in conflicts worldwide since the 1990s. United Nations preventive diplomacy and other forms of preventive action have quelled many potential conflicts.

Common criticisms are: perceived ineffectiveness of the body (including its complete ineffectiveness in both prevention and mitigation of existing conflicts ranging from social strife to full-blown warfare), anti-Semitism, appeasement, collusion, Promoting globalism, inaction.

These reforms are based on three pillars:

(1) Reposition the United Nations development system in the best position to advance towards the 2030 Sustainable Development Goals; (2) Pursue management reforms that simplify processes, work towards gender equality, streamline personnel processes, and generally create a more efficient organization; (3) restructuring peace and security operations to better meet today's challenges;

The reform aims to make the United Nations more agile, less bureaucratic, more transparent and accountable, more decentralized and effective.

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