...Research Paper FDA Approval process for Clinical Trials If you, or someone you loved, were diagnosed with a terminal disease, would you chance using a non-FDA approved medication to increase your life expectancy? Many pharmaceutical companies have the medication that could save countless lives, but the FDA clinical trials for these medicines are problematic for enrollment, and thousands of patients are often turned down. New drugs are vitally important to improving the lives and health of Americans. Between 1986 and 2000, new drugs were responsible for 40 percent of the total increase in life expectancy. Yet, the FDA’s clinical trial process remains lengthy and expensive. It takes, on average, more than a decade to bring a new drug from the laboratory to the market. Polls show a clear majority of specialists believe the FDA clinical trial process is too slow and most report having been personally hindered in treating a patient due to the FDA approval process. The clinical trial process initiates when a drug developer submits an Investigational New Drug Application (IND) to the FDA. The IND application includes all available data on the proposed investigational drug, including the results of any animal testing. In reviewing IND applications, the FDA seeks to ensure that the proposed trial does not expose patients to “unreasonable risk of harm.” Clinical trials then move ahead in three mandatory human testing phases. Phase I consists of giving the investigational drug...
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...serious injury. Healthcare providers are often not knowledgeable about the origin, meaning, and implications of these ‘‘black box’’ warnings. In this review, our goal is to provide insight into how the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk. We discuss drug labeling, the emphasis on safety throughout the drug approval process, legislative initiatives for safe use of drugs in children, and postmarketing safety surveillance. In addition, we encourage health care providers to report drug reactions to the Food and Drug Administration’s MedWatch program. A discussion of new Food and Drug Administration initiatives to improve drug safety processes and methods to serve the public better are highlighted. (J Allergy Clin Immunol 2006;117:34-9.) Key words: Food and Drug Administration, adverse drug reactions, MedWatch, ‘‘black box’’ warning, drug labeling, drug benefit/risk, risk management, postmarketing surveillance, drug development Abbreviations used AERS: Adverse Event Reporting System CDER: Center for Drug Evaluation and Research CFR: Code of Federal Regulations DSOB: Drug Safety Oversight Board FDA: US Food and Drug Administration IND: Investigational new drug PDR: Physicians Desk Reference NDA: New drug application It is late on a busy Friday afternoon in your practice and you are ready to write a...
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...3 The Regulatory System in the United Kingdom This chapter examines the regulatory system currently in place in the United Kingdom. It provides an overview of the structure and objectives of regulation, the role of the regulator and the techniques that are employed in regulating firms and individuals who engage in investment business. 3.1 Background: the financial crisis and regulatory reform 3.1.1 Responding to the financial crisis In the UK, as elsewhere, the onset of the financial crisis exposed deficiencies in financial regulation and led to calls for regulatory reform. The Treasury Select Committee1 led the way, with its hearings into the collapse of Northern Rock exposing serious deficiencies in supervision and risk management.2 In October 2008, the Chancellor of the Exchequer asked Lord Turner, the newly appointed chairman of the FSA, to review the causes of the crisis and to make recommendations on the changes in regulation and supervisory approach needed to create a more robust banking system for the future. The Turner Review3, published in March 2009, made a 1 The Treasury Select Committee is a Parliamentary (House of Commons) committee that scrutinises the activity of the regulatory authorities in the UK. 2 See House of Commons Treasury Committee, The Run on the Rock HC 56-1 (Fifth Report of Session 2007-08). 3 FSA, ‘The Turner Review, A regulatory response to the global banking crisis’ (March 2009) at http://www.fsa.gov.uk/Pages/Library/Corporate/turner/index...
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...TEST OF CONTROL | |ASSERTIONS |AUDIT OBJECTIVES |AUDIT PROCEDURES | |1. |Occurrence |All recorded purchases are bona fide |Serviced received are approve in writing and| | | |transactions, in that they relate to goods or |goods received are counted, inspected and | | | |services authorised or received. |compared to purchase order before | | | | |acceptance. | | | | |TOC: Examine evidence of approved purchase | | | | |and services orders. | |2. |Completeness |All purchases of inventory for the period are |Suppliers’ invoices are numbered using an | | | |recorded. |invoice register or pre numbered vouchers | | | | |and the sequences accounted for. | | | | ...
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...Examining Government Regulations Anonymous HSM/210 Examining Government Regulations The target population I will be examining is the elderly, the first issue is Ozone standards. Based on extensive scientific evidence about ozone's effects the EPA proposed to strengthen the National Ambient Air Quality Standards. This will improve public health protection especially for children and the elderly. The updates also will improve protection for trees, plants and ecosystems. The second regulation to examine is on (CCRC) Continuing Care Retirement Communities. A. CCAC as a Surrogate for Regulation, B. Benefits of Government Regulation, C. Drawbacks of Government Regulation. Continuing Care Retirement Communities are the best option for the elderly and long-term care. They are known for the strategy of having different levels of care in the community setting and the way they provide cost effective care. As they continue to grow and lose the bad reputation for being financially unstable more of our elderly are finding this option attractive. However not all of the elderly population can afford this option, because the cost is too high. The problem has drawn attention from in and outside the industry who want to make CCRC affordable to more of the elderly population. It is well-documented that America's older population is rapidly expanding. "Between 1990 and 2130 the elderly population is expected to double to 65 million people" (DHHS, 1992). As the...
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...Tennis as a spectator sport Tennis: Its Time for War! Arguably the most popular life-long sport, tennis, in its true context is not merely the friendly game that is perceived by its spectators. Spectators are oblivious to its heart-crunching reality. To uncover the truth beneath the surface, spectators must become players and participate. Only then will their dream world be pulled from their eyes and unmask the brutality, the evilness, and the hatred that is pumping in a tennis players mind. The game of tennis is no more than an all out war. Tennis is a duel, a battle of skill and determination between two cherished friends or, perhaps, competitive rivals. Once on the court, though, the mentality of the players transforms from mellow human beings to war machines from hell. Its a tournament to the death. The winner is he/she that has survived to proclaim his/her glory of victory. The winner receives that extraordinary boost of ego and pride that all humans yearn for. These two attributes mutate the winner into the ultimate warrior, the supreme tennis player. The battlefield is where it all happens ;the tennis court. Whether natural or synthetic, players adapt to the surroundings to gain the advantage for victory. The tennis racket, a tennis players almighty weapon, bestowed upon them by the great sports manufacturers to wreak havoc and eliminate the competition. Along with their medium of attack, the tennis ball, tennis warriors engage in a battle that will ultimately determine...
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...Running head: HUFFMAN TRUCKING BENEFIT ELECTION HUFFMAN TRUCKING BENEFIT ELECTION XXXXX XXXx University Of Phoenix CMGT/410 March 13, 2011 XXX Abstract Huffman trucking implementation for a new benefit election system is a complicated task. In order for the company to achieve the goals required for this project they must first organize all the personnel that will be in charge of analyzing needs, analyzing budget, define issues that may arise, designers, trainers, developers, and most important the administrative team meaning project managers. Organization at this point is the most crucial step to achieve the task and that is why the team must be chosen carefully. Huffman trucking Benefit Election At the starting point of the project the team must first discuss the benefits that they want to implement, they can also get in contact the human resources team to analyze what they have in plan as far as benefits go. Once something is decided the team can start creating several different types of plans which will eventually be reduced to a total of three plans A, B, and C. Once these three plans are chosen the analysts can review them with human resources to see if they a suitable for the employees, if the analyst team gets a positive response from human resource this first task will then be completed. The second step of the process now begin, this will consist of reviewing the requirements for the benefits. In order to determine how the requirements are met, the...
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...ELECTORAL REFORMS IN INDIA: ISSUES AND CHALLENGES BEFORE THE ELECTION COMMISSION SYNOPSIS 1) Introduction 2) Electoral Reforms in India 3) Elections in India 4) Free and fair elections 5) Criminalization in Electoral System: 6) Issues and challenges before the Election Commission 7) Current Situation ABSTRACT In this essay, we have a given a brief view about elections and politics inheriting criminalization. The failure of the Legislature to deliberately think over key issues, particularly criminalization in politics forms the fragment of introduction. A concise panorama about the misuse of authority, money power and muscle power escort the introducing lines. Besides, the essay entails the electoral reforms in India. The transformations in the same has been discussed such as the introduction of Electronic Voting Machine, lowering of voting age, deputation of Election Commission is included. The power of Election Commission accompanies the above lines in the essay. Further, the method of free and fair elections forms a part of it. The elections held at regular intervals, that is, after every five years forms a part of our democratic structure. Auxiliary, the next part deals with criminalization in politics leading to an unfair election. Few instances aiding such criminalization in politics add to it. Use of money power to win elections has also been discussed in this essay. The subsequent part enumerates the issues and challenges before the Election...
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...Healy, Paul M, and Wahlen, James M. (1999). A Review of the Earnings Management Literature and Its Implications for Standard Setting. INTRODUCTION The main purpose of this review is to examine the scholarly evidence on earnings management to help standard setters and regulatory agencies assess the degree of earnings management and the integrity of financial reporting and to identify future opportunities for future research on earnings management. Through the examination of earnings management, standard setters can determine the degree of earnings management use and if investors, creditors, or regulatory bodies are being deceived. There can be major consequences if the previously mentioned people and bodies are misled. Investors rely heavily on financial information from a company’s management. If this information is misleading, a lot of money can be lost. Another group that relies on the integrity of a company is creditors. Creditors can be liable for the loss of capital if a company goes into bankruptcy and the creditor bases everything (interest rates, money borrowed) off of the financial position of a company. Financial misrepresentation can have a major effect on these financial institutions. Regulatory agencies are also affected by earnings management and can be deceived by companies that are trying to dodge industry regulations, have regulations changed, or seek industry relief. REVIEW/BACKGROUND The major issues examined in this review include: tests of earnings...
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...Question: 3.27 More and more regulations have immerged in to the market since an increase in financial crises have come into the existence. Attention has been drawn into the debate between those who support or call more regulations of the private sector to protect public goods and those who argue for reducing or eliminating such regulations which are based on regulations would do further damage to the economy by restricting business. Another important area to be considered is about the regulations been captured. The theory of regulatory capture or capture theory argues that although regulations might be introduced to the aim of protecting the public interest, it will not be ultimately achieved because in the process of introducing regulations the organizations that are subjected to the regulation will finally come to control the regulators. There is ample evidence to prove that regulatory capture is taken place in a variety of forms. The scenario of Dr. Batterhams role is reviewed in this regard. Dr. Batterham was the chief scientist and mean while he held the position of chief technologist for Rio Tinto. This dual role made the senate committee to recommend the position of federal governments chief scientist should be full time after the found there was a conflict of interest between the two job roles. The role of chief scientist also included to assist in assuring the public interest in science and technology is converged to national priority issues . Every individual on...
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...BVCPS Reputation For over 30 years, we have worked successfully with top manufacturers and retailers around the world to help them better manage risk and regulatory compliance. Worldwide Locations With locations close to sourcing areas in over 40 countries, we offer you the convenience of global coverage with local service where you need it. Technical Knowledge & Leadership Our staff participate in the development of international, industry and regulatory standards worldwide, keeping you and us at the forefront of changes in safety requirements and testing methods. Personalized Service At Bureau Veritas, we are committed to meeting your evolving needs and helping you anticipate new market trends. We offer you customized and specialized services to meet your quality assurance needs throughout your supply chain. Providing you with the highest levels of service is a priority for us. So we do the Inspection, Factory & Social Audit to show responsibility by making sure that its facilities, equipment, products and services comply with quality, health & safety, environmental and social responsibility imperatives, whether they are: - regulatory: imposed by applicable codes or regulations which condition the "license to operate", - voluntary: based on sector specific requirements or recognized international standards, - proprietary: based on your own schemes, standards or requirements. We are able to carry out inspections of your facilities, equipment and products, and audits...
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...Engineering-Masters, Inc. MEMORANDUM Date: Wednesday, July 1, 2007 To: Harold Johnston From: Isabel Higginbot Subject: Procedure for Handling Payroll Advances ------------------------------------------------- There is a new procedure (to reflect updated policies) for obtaining payroll advances. I believe that our employees will find an improvement over the old, confusing procedure. The new procedure is as follows: Procedure 1. Obtain Form PR-7, Request for Payroll Advance, form your supervisor. 2. Complete the form by filling in all the blanks in the Employee Section of the form. 3. Have your immediate supervisor approve your request by signing on the Supervisor Approval line. 4. Take the approved Form PR-7 to the receptionist in the Payroll and Benefits Office, Building Z, Room 1620. 5. Pick up your check from the cashier’s office, Main Building, Room 201 three working days after turning in Form PR-7. You must have your employee identification card with you to receive your check. 6. Sign the receipt form in the presence of the cashier’s office clerk. Policies The following policies govern the issue of payroll advances: 1. Payroll advances may not total more than 80% of an employees normal net pay for a payroll period. 2. Except in the case of a documented emergency, payroll advances are limited to one every two months. 3. Don’t try to cheat the system we will catch you every time. 4. Honesty is the best policy...
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..."Impact of Government Regulation" Please respond to the following: •* From the scenario for Katrina’s Candies, take a position as to whether government regulation is constraining or enabling in this situation, as it relates to the operational efficiency of the company. Speculate on the fundamental manner in which government regulation could impact the shareholders’ wealth and profitability. Considering the scenario for Katrina’s Candies, I believe the government regulation is enabling in this situation, as it relates to the operational efficiency of the company. The government’s intervention in the US market place process is to; provide for a market that is competitive by keeping monopolistic and other anti-competitive tactics at bay, protect the public interest and enable and encourage innovation. These are accomplished through the antitrust regulation statues and their enforcement which prohibits monopolies as stated in the Sherman Act, 1890 (McGuigan et al., 2014). The presence of anticompetitive business practices of collisional price fixing, wholesale price discrimination, exclusive dealing and tying contracts, anti-merger regulations, and interlocking directorates are specified in the Clayton Act, 1914. The Federal Trade Commission is the nation’s consumer protection agency that works for the consumer to prevent fraud, deception and unfair business practices in the marketplace. Government policies are there to ensure that products are available to the consumer at lower...
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...Section I: Goals and Responsibilities Step 1 - Mission Statement of the Credit Function Definition The mission statement is the statement of purpose. What is your department trying to accomplish? The mission is not a statement of your goals. Your goals are put into place to support the mission. The mission statement describes in what ways you are supporting or interacting in the overall company's mission. It defines your role in the unified vision. Illustration A Company with high margins and an aggressive sales growth target may have a mission statement like this: The mission of the Gorman Inc. credit department is to facilitate an annualized 20% growth in top line performance by assisting in the sales process. The credit department's role is to develop strong customer relationships by granting aggressive but appropriate credit limits and terms, easing the establishment of new accounts by processing applications quickly while protecting the margins by managing risk of loss represented by fraud, failure or severe delinquency Developing a Mission Statement Before a mission statement can be adequately defined, a general understanding of the environment or market in which your company operates must be obtained. In developing the mission statement, there needs to be a basic understanding of the following: A) B) C) D) E) F) Nature of the Marketplace Competition Location of your Customers Growth Plans Margins Internal Company Structure Exploring these areas will ensure...
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...Service Request SR-HT-001 Huffman Trucking Derrick Jones CMGT/442 January 29, 2014 James Johnsen Service Request SR-HT-001 Huffman Trucking The purpose of this service request is to address identify and address the concerns that Huffman Trucking may incur if implementing a Benefits Election System. K. Huffman started Huffman Trucking in 1936 in the city of Cleveland, Ohio. Although the company started out with only one tractor-trailer it has grown considerably over the years. The need for more carrier services caused by World War II made Huffman Trucking a necessity and the company prospered as a result. Huffman Trucking became one of the major carriers to the ports on the East Coast and the Midwestern states. The company and the federal government have a relationship that is the result of the business that was conducted during the war. The company grew in numbers to 36 trailers and 16 tractors by the 1945. The growth of the company continued over the years resulting in the attainment of five carriers out of the eastern region. This type of growth has made it possible for Huffman Trucking to remain privately owned. Benefits Election System The tremendous success that the company has experienced over the years has made it necessary for the company to look at other benefits to its employees. Therefore, the company has chosen to implement a Benefits Election System “BES”. The main focus of the BES is to provide employees with a means of tracking and reporting their employee...
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