Explores some of the legal and ethical issues surrounding the legal sale of drugs that have not been approved by the FDA.
Essay # 32894 |
2,400 words (
approx. 9.6 pages ) |
2 sources |
2002
|
$ 44.95
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Abstract
The U.S. Food and Drug Administration regulates many of the products you use in every day life. Yet, there are many drugs on the market that have not been approved by the FDA. This paper examines the legal and ethical issues that surround these lawful, yet unapproved by the FDA, drugs that are on the market.
Tags:drugs, fda, unapproved
A critical examination of the Food and Drug Administration (FDA)'s approval process for new drugs.
Term Paper # 115956 |
2,034 words (
approx. 8.1 pages ) |
11 sources |
MLA | 2009
|
$ 38.95
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Abstract
The paper relates that the FDA has been accused of being too slow as well as lacking oversight and in need of even more periodic reviews of previous approvals. The paper discusses the pressure from patient groups as well as doctors and pharmaceutical companies to expand the FDA approval and testing process to include experimental drugs. The paper devotes time to the politicization of the FDA and the accusations of bias towards the pharmaceutical companies. The paper also reveals that many American pharmaceutical companies are now outsourcing their clinical trials, which might make it more difficult for the FDA to follow every step of the trial method and results.
From the Paper
"Just what does the FDA do? Government documents state that the FDA seeks to protect the public health by ensuring the purity and security of foods; the safety and effectiveness of drugs, medical devices, biological products, and radiation-emitting products; and the safety of cosmetics. The FDA oversees the review and approval of new medicines and medical devices. It also monitors the safety of dietary supplements, though it does not review and approve the supplements before they are sold.
"The FDA helps to ensure that people receive accurate information about the foods and drugs that they use. The agency calls for the truthful description of product benefits and risks and for safety and honesty in packaging. In fact, the information about contents and dosage found on food packages was developed by the FDA."
Tags:oversight, testing, safety, medication, lobbyists
A case study analysis of the Food and Drug Administration (FDA) process to approve the drug, Viagra.
Case Study # 118787 |
2,151 words (
approx. 8.6 pages ) |
7 sources |
MLA | 2010
|
$ 40.95
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Abstract
This paper examines the process to get a drug to market. The paper specifically focuses on the case of the drug, Viagra. It looks at the patent laws on new drugs and how drug companies will often try to extend their patents to extend the fiscal life of a drug. The paper discusses the essential stages of the Food and Drug Administration (FDA) process to approve new drugs and how the public can have access to cheaper generics while maintaining the quality of the product.
From the Paper
"For pharmaceutical drug companies like Pfizer to remain profitable and continue to offer premium products, the solution is simple. Give the new drug's inventor the exclusive rights to sell the drug for 15 years after the day the drug is approved. Currently, patents protect drugs from copycat versions for 20 years after the drug is invented. Since it often takes eight years or more to obtain approval, this essentially reduces the patent expiration to less than eleven years. Expensive lawsuits eat into the company's profit margin, inhibiting their ability to continue research and development into other drugs. In short, this solution will still give the public access to cheaper generics while maintaining the quality of the product."
Tags:generic, patent, Pfizer, patent
This paper discusses reforms approved by the Roman Catholic Church.
Essay # 74568 |
2,475 words (
approx. 9.9 pages ) |
16 sources |
2004
|
$ 45.95
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Abstract
In this article, the writer presents an analysis of the reforms approved by the Roman Catholic Church as a result of the Second Vatican Council (Vatican II). The writer discusses their impact on theology and the laity.
Tags:Pope John Paul, religion, theology, scripture, ecumenism, natural rights of man, mass, divine revelation, God, Christ, doctrine, Roman Catholic Church
This paper discusses that Immanual Kant could have never supported the US invasion(s) of Iraq over the past 18 years.
Argumentative Essay # 114977 |
1,400 words (
approx. 5.6 pages ) |
2 sources |
APA | 2009
|
$ 28.95
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Abstract
In this essay, the writer shows that there is no way to twist the Kantian doctrine of the categorical imperative (CI) to justify the various invasions of Iraq that have been led by the United States since the early 1990s. The writer first explains Kant's categorical imperative and discusses its application to international affairs. The writer then asserts that there is simply no way to hold that the CI applies to the US government in the Iraqi case. Various points to support this argument are examined and the writer then concludes that Kant could in no manner have approved of the various invasions of Iraq based on the principles inherent in the categorical imperative.
From the Paper
" To use a more local example: Consider the government of New York City. Consider that it has several street gangs on its payroll, doing some of its dirty work in the slums. It favors one, a particularly violent gang called the Tels, that it finances and arms to the teeth, including advances, high tech weapons. Another street gang, called the Bags, was also at one time on NYC's payroll, but recently went afoul of the government by hitting several smaller gangs in the region. The city government could not use the CI to justify eliminating the Bags, partially because in supporting gangs in general, there is no altruistic motives, but purely political and personal ones (i.e the gangs can do what the city cannot against its enemies), but also partially in that it has been supporting the Tels, that regularly pick on its neighbors in a harsh manner, all with the open approval of the NYC mayor's office."
Tags:morality, state, autonomy, principles, universality
Researches the performance of federal mortgage lending agencies and conventional lenders in relation to both risk-based pricing policies and higher mortgage loan limit policies.
Essay # 26897 |
1,549 words (
approx. 6.2 pages ) |
20 sources |
MLA | 2002
|
$ 30.95
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Abstract
This study investigated the effects of programs dealing with risk-based pricing and increased mortgage loan limits on mortgage approval rates for low- and moderate-income households. The research performed for the study found that risk-based pricing policies did have a positive impact on the extension of residential mortgages to low- and moderate-income applicants, in that rejection rates associated with risk-based factors declined. The research performed also found that higher mortgage limit policies had a positive impact on the extension of residential mortgages to low- and moderate-income applicants, in that rejection rates associated with risk-based factors declined. Lastly, the research results indicated that higher mortgage limit policies had a greater positive impact than did risk-based pricing policies.
Table of Contents
Introduction
Problem Statement
Research Questions
Study Purpose
Significance of the Study
Definitions of Terms
Delimitations of the Study
Overview of the Remainder of the Study
Review of the Literature
Systems Theory
Systems Theory and the Mortgage Lending Model
Mortgage Lending Markets
Past Discrimination in Mortgage Lending
Summary
Methodology
Research Design
Research Hypotheses
Variables and Operational Definitions
Data Collection
Data Analysis
Methodological Limitations
Summary
Results
Problems with the Data
Restatement of the Research Questions
Restatement of the Hypotheses
Restatement of Operational Definitions
Restatement of Data Analysis Procedures
Research Results
Summary, Discussion and Conclusions
Discussion
Conclusions
Appendix: Data Tables
Bibliography
From the Paper
"The effort to improve accessibility to residential mortgage finance for low- and moderate-income individuals and families tends to be impeded by a system that has become entrenched. This existing system is an interlocking structure of public and private sector players that has developed rules and processes with which they are comfortable and which they are reluctant to change. The existing system for the extension of residential mortgages also involves both the primary and the secondary mortgage markets, as well as credit review and reporting agencies. The system in place was never intended to provide access to residential mortgages to low- and moderate-income persons except within the framework of specific governmental programs targeting such individuals. These specific programs involved direct public funding, government guaranteed repayment of loans extended by private sector lenders, or subsidies to developers and builders."
Tags:bank, loan, real, estate, federal, assistance
This paper discusses the transmission of norms and values in the classroom and the decisions about what is socially approved knowledge.
Essay # 53961 |
1,775 words (
approx. 7.1 pages ) |
4 sources |
APA | 2004
|
$ 34.95
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Abstract
The paper explains that hidden curricula can be divided into two types: conscious, such as the religious tracts;and unconscious, which tends to be more influential simply because it is not easily discovered. The author reviews the research of Jean Anyon who studied elementary schools in communities of differing social class to discover the hidden curricula at work. The paper examines four schools from four different social classes. In the executive elite school, children are given knowledge of and practice in manipulating the socially legitimated tools of analysis of systems; this was not give to other schools.
Table of Contents
Introduction
Class as a Comprehensive Example of Hidden Curricula
Forlorn Hopes, Prescription for Delinquency: The Working Class School
Birthing Bureaucrats: The Middle Class School
Pretty Good Expectations: The Affluent Professional School
Getting Used To Power: The Executive Elite School
From the Paper
"Jackson seems to have believed that the hidden curriculum theory can be applied to many explanations for differences in educational achievement, including curricula based on such things as class, gender and ethnicity. In the current age, the term "No child left behind" is tossed about as a model for education. And yet, educational budgets for public schools are being cut to extraordinarily low levels due to budget cuts both nationally and locally. It would seem that the hidden curriculum based on social class might currently be at the forefront of impactful hidden curricula. A study of this area will shed light as well on what teacher expectations; student self-concept and more contribute to the hidden curricula and the educational results, especially in the public school system most affected by budgetary crises."
Tags:achievement, social-class, self-concept, manipulating, research
This paper discusses Socrates' view of what is holy and what is divinely approved.
Essay # 33949 |
1,150 words (
approx. 4.6 pages ) |
1 source |
2002
|
$ 23.95
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Abstract
This paper explains that the philosopher succeeds in showing that these two concepts are very distinct. The author states that this issue applies to the concepts of truth and virtue because truth and virtue end up having a direct connection to that the gods think about them.
This paper discusses the laws concerning the export of non-approved drugs by U.S. manufacturers to European countries: Food and Drug Act, industry background, business issues, ethics, need for reform, global regulations and future.
Research Paper # 21816 |
4,500 words (
approx. 18 pages ) |
30 sources |
1995
|
$ 70.95
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From the Paper
"This paper will discuss some aspects of the laws concerning the export of non-approved drugs by U.S. manufacturers to European countries. The first part will provide a brief background to the issue, describing the development of the modern pharmaceutical industry and exports. The second part of the paper will discuss some of the most important business issue involved in the export of drugs. The third part of the paper will consider some of the important ethical issues concerning the export of drugs. The fourth part of the paper will examine the U.S. laws and international agreements governing the export of drugs developed in the U.S. The conclusion will consider the future of drug exports and some possible approaches to the problems."
An examination of the roles of U.N.-approved international organizations in the creation and implementation of international agreements.
Research Paper # 19338 |
3,375 words (
approx. 13.5 pages ) |
24 sources |
1992
|
$ 57.95
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From the Paper
"Introduction
A non-governmental organization (NGO), according to the U.N., is any international organization not established by intergovernmental agreement. To qualify for consultative status at the U.N., an NGO must be of service in the Economic and Social Council's field of interest, act in the spirit of the U.N., be non-profit and possess the means to implement its objectives.1
Non-governmental organizations play a key role by initiating programs of information and education and have indirect effects by mobilizing public opinion and furthering the ends of human rights advocates.2 Codes of conduct and uniform laws usually are prepared by nongovernmental, as well as international intergovernmental, organizations, and are aimed at universal or regional unification of substantive laws. Some of the laws..."