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
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$ 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
An analysis of business process reengineering steps taken to streamline an Information Technology service request system.
Research Paper # 6408 |
3,400 words (
approx. 13.6 pages ) |
4 sources |
APA | 2002
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$ 57.95
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Abstract
The current IT Service Request system or flow of data is out of date, slow and too dependant on manual interaction such as management approval and outsource hand-off. This project re-engineers the processes of this flow creating a new IT Service Request management system that encompasses the data flow, process flow, automation through information technology and process ownership. Overall, the entire flow of IT service requests are visited to determine where unnecessary steps can be taken out, where steps can be shortened, and where steps can be automated.
From the Paper
"The organizational structure of the company is in a traditional tall functional structure. The sub-organizations are split into their respective functional areas such as engineering, human resources, finance, manufacturing, information technology, etc. There are a total of three levels of business separations at the high level of company organizational structure.
The above shown organizational chart represents a sample of the high level corporate structure. At the first level resides the corporation. Next is the separation of independent businesses within the Raytheon Company structure. Finally, the last high level organization is the Business Unit which represents the specialized business areas within the major area of business. For example, Electronic Systems, Raytheon Company deals with all defense electronics technologies. Within the Electronic Systems business, there are several business units such as Missile Systems and Tactical. Within each business unit, there exists an entire structure of functional management. "
Tags:bpr, business, information, process, reegnineering, technology, tqm
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
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$ 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 studies the role and the process of budget estimates.
Narrative Essay # 74611 |
1,300 words (
approx. 5.2 pages ) |
3 sources |
APA | 2006
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$ 26.95
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Abstract
The aims of this paper are to identify the stages of the budgeting process and to evaluate their effectiveness. The article evaluates the level and validity of detailed assumptions used to create budget estimates. It discusses the role of the budget as an analytic tool that can be used to evaluate organizational performance. The writer explains how the budget can be used to find and eliminate inefficiencies in an organization's performance and explains the role of the budget in the business control cycle. The author analyzes internal and external control mechanisms that can be put in place to monitor and evaluate the budget and describes how the budget can be used in the performance accountability and reward process. The writer makes use of the example of a major business initiative in an organization that was approved last year as a result of the budget process, and explains how the budget was used in the approval process.
From the Paper
"There are four stages in most budgeting processes. The first stage is information gathering. At this stage past performance results are collected and assessment is made of the company's strategic plans. Performance results for the previous year are gathered, the company's current objectives are defined and the market in which the company operates is evaluated. Some companies also include customer feedback in their information gathering tasks. Planning is the second stage, with determinations made about how detailed the budget will be and how it will be organized, whether by department or product or other groupings."
Tags:accounting, finance, business, plan
A look at the process of bringing a new drug to the marketplace, focusing in particular on Zometa, or zoledronic acid.
Analytical Essay # 132641 |
3,250 words (
approx. 13 pages ) |
0 sources |
MLA |
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$ 56.95
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Abstract
This paper looks at the process of bringing a new drug to the marketplace, focusing in particular on Zometa, or zoledronic acid. The paper explains that bringing a new drug to the market is an involved process. The research and development on a new drug is expensive and time-consuming, followed by lengthy trial and a lengthy approval process for the Food and Drug Administration. As noted, the process can take years before the drug is allowed to be sold on the market. A case in point is the drug Zometa. Zoledronic acid (Zometa) is used for the treatment of Osteolytic Bone Metastases. The drug is a bisphosphonate derivative.
From the Paper
"Bringing a new drug to the market is an involved process. The research and development on a new drug is expensive and time-consuming, followed by lengthy trial and a lengthy approval process for the Food and Drug Administration. As noted, the process can take years before the drug is allowed to be sold on the market. A case in point is the drug Zometa. Zoledronic acid (Zometa) is used for the treatment of Osteolytic Bone Metastases. The drug is a bisphosphonate derivative. The drug is used as a support medication for treating symptoms of cancer (such as hypercalcemia) or to decrease complications from bone metastasis. The drug can be infused .."
Tags:cancer, drug, trial, FDA, ostelytic
Fat-free food additive. Examining development and testing of the product and the FDA approval process. Looks at olestra's chemistry, uses, safety & side effects.
Essay # 13085 |
1,800 words (
approx. 7.2 pages ) |
13 sources |
1997
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$ 34.95
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From the Paper
"OLESTRA
Olestra is a chemical fat-free food additive which was conditionally approved by the Food and Drug Administration (FDA) on January 24, 1996 for use in savory snack foods. A major new food product developed by Proctor & Gamble (P&G) at great expense, potato chips containing olestra underwent test marketing in supermarkets in three American cities, Eau Claire, Wisconsin, Cedar Rapids, Iowa and Grand Junction, Colorado in May and June, 1996). Olestra potato chips will soon to be introduced on a mass-marketing basis in retail stores throughout the nation. This latest addition to the junk food market has generated considerable controversy because of concerns expressed in health and scientific quarters regarding its possibly deleterious effects on human health."
Origins, functions, approval process, powers & implementation, organization and rule-making of this corporation.
Research Paper # 20535 |
3,150 words (
approx. 12.6 pages ) |
4 sources |
1993
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$ 54.95
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From the Paper
" INTRODUCTION
The federal Food and Drug Administration (FDA) is a complex organization with diverse responsibilities. Although now considered essential to the well-being of the nation, federal regulation of food and drugs has not always existed. This paper will explore the FDA's regulatory functions by first examining how the organization came to fill the regulatory void in food and drug law. Attention will then be given to the more important aspects of regulation, including a structural analysis of the FDA's functions. After examination of agency functions, the rulemaking powers and procedures of the FDA will be analyzed in detail.
REGULATORY FUNCTIONS: AN HISTORICAL PERSPECTIVE
The regulation of food and drugs is not a newfound.."
A look at its development, international issues (competition, trade, controls), costs and the type-approval process.
Essay # 20302 |
2,025 words (
approx. 8.1 pages ) |
8 sources |
1993
|
$ 38.95
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From the Paper
"Cellular telephones constitute a new and growing industry that has made advances in the United States and that is now seeking to expand through trade with other countries. Standard and Poor emphasize that this is necessary in the entire telecommunications industry:
The stagnant domestic market and widening overseas opportunities--a result of privatization of telephone companies and the opening up of Eastern Europe--have created a market where manufacturers need to have a truly global orientation in order to be successful..
From a financial standpoint, cellular technology has become more affordable to a wider range of people. New technology and the introduction of economies of scale have added to the downward..."
A discussion on the proposal to facilitate new drug approval in Great Britain's National Health Service (NHS).
Term Paper # 149479 |
1,059 words (
approx. 4.2 pages ) |
2 sources |
MLA | 2011
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$ 22.95
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Abstract
The paper discusses how the nature of the British healthcare system is to discourage rather than encourage healthcare usage, and this system has created a very cost-efficient model for the UK. The paper explains, however, that this frugality means that bypass surgery, dialysis, and medications in general are much more rarely prescribed in the UK than in the US. The paper relates that to address the problems of under-medication, there has been a proposal to allow drug companies in the UK with "innovative" medicines to bypass the current screening process for cost-effectiveness. The paper points out that this new policy could result in fewer NHS funds for more necessary procedures and drugs that could help more people, but also notes the economic and medical arguments for approving this proposal.
From the Paper
"Private insurance and expanded and expedited care is possible because unlike Canada, Britain allows citizens to hold supplementary insurance. As well as NHS care, patients can opt for care for which either they or their private insurer (or a combination of both) must pay. 11% have some form of employer-provided or private insurance, and "many jobs offer it as a perk" (Klein 2009). "To accommodate this, doctors can have both private and public practices, meaning they can treat patients under public rules complete with queues for non-pressing procedures while, at the same time, be performing the same procedures with quick turnaround for those with supplementary private insurance" (Klein 2005). Unsurprisingly, this has caused a great deal of discontent about such apparent inequality in a system which, at least in spirit, is supposed to be based upon the principle of equal care for all. The tension because of the disparity of quality that exists between public and private care has only been exacerbated in recent years, as expensive and rare drugs and treatments that the NHS will not cover continue to proliferate. Thus, there has been a call for expanded access and coverage to such expensive and innovative care under the NHS--even while funding has been cut."
Tags:medications, pharmacy, healthcare
A comparison of the scandals which entangled Nixon's and Clinton's presidencies, with an analysis of why Nixon was forced to resign while Clinton left office with a high rating of public approval.
Comparison Essay # 66238 |
2,256 words (
approx. 9 pages ) |
21 sources |
MLA | 2006
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$ 41.95
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Abstract
The paper compares the presidential scandals of Richard Nixon and Bill Clinton. First the paper reviews the Watergate scandal, and explains that this was just the tip of the iceberg, analyzing the machinations behind the break-in and reasons for it and its subsequent cover-up, and finding extensive criminal wrongdoing to be at the heart of the matter. Next, the paper focuses on President Clinton's sexual escapades, and analyzes why the press played up the story yet Clinton survived the impeachment process. Following this, the paper reviews various analyses of presidential personality and public perception, comparing the two Presidents, and focusing finally on the Meyer's Briggs Type Indicator of personality to show that Clinton was an Artisan while Nixon was a Guardian. The American public will, the paper informs us, love an Artisan despite his flaws, but respect a Guardian only in the absence of visible flaws. In conclusion, the paper finds that it is both the public perception of the respective Presidents' personalities, and the presence or absence of criminal wrongdoing, which caused Clinton's name to be praised while Nixon's is derided.
Table of Contents:
Introduction
Nixon and Watergate
Clinton and Travel Gate etc.
Presidential Personalities
Conclusion
Footnotes
Bibliography
From the Paper
"History tells us that most likely, Nixon did not know in advance about the break-in and that his press secretary dismissed it as a "third-rate burglary." President Nixon lied when he assured the nation that "The White House has had no involvement in this particular incident". By the time of the press conference, he knew that several present and former White House employees were linked to the Watergate burglars. Nixon already had begun to cover those links by the time he asserted the White House's lack of involvement."
Tags:Watergate, scandal, impeachment, Meyers, Briggs