...Order Code RS22814 February 21, 2008 FDA Fast Track and Priority Review Programs Susan Thaul Specialist in Drug Safety and Effectiveness Domestic Social Policy Division Summary By statutory requirements and by regulation, guidance, and practice, the Food and Drug Administration (FDA) works with several overlapping yet distinct programs to get to market quickly new drug and biological products that address unmet needs. FDA most frequently uses three mechanisms for that purpose: Accelerated Approval, Fast Track, and Priority Review. The first two affect the development process before a sponsor submits a marketing application. Accelerated Approval allows surrogate endpoints in trials to demonstrate effectiveness and is relevant in fewer situations than the others. The Fast Track program encourages a sponsor to consult with FDA while developing a product. Unlike the others, Priority Review involves no discussions of study design or procedure; it relates only to an application’s place in the review queue. Analysis of total approval time for approved applications under the Fast Track and Priority Review programs shows that for seven of the past nine years, Fast Track products have shorter median approval times than do all those applications assigned to Priority Review. It takes an average of 15 years from the moment a manufacturer first approaches the Food and Drug Administration (FDA) with an idea for a new drug to its final approval for marketing.1 Steps...
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...Chapter 1 Auditing and Internal Control Review Questions 1. What is the purpose of an IT audit? Response: The purpose of an IT audit is to provide an independent assessment of some technology- or systems-related object, such as proper IT implementation, or controls over computer resources. Because most modern accounting information systems use IT, IT plays a significant role in a financial (external audit), where the purpose is to determine the fairness and accuracy of the financial statements. 2. Discuss the concept of independence within the context of a financial audit. How is independence different for internal auditors? Response: The auditor cannot be an advocate of the client, but must independently attest to whether GAAP and other appropriate guidelines have been adequately met. Independence for internal auditors is different because they are employed by the organization, and cannot be as independent as the external auditor. Thus internal auditors must use professional judgment and independent minds in performing IA activities. 3. What are the conceptual phases of an audit? How do they differ between general auditing and IT auditing? Response: The three conceptual phases of auditing are: i. Audit planning, ii. Tests of internal controls, and iii. Substantive...
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...Review Of the Movie “The Help” “The Help”, it is a movie based on the book which contain testimonials on the experiences of African-American maids. I remembered I read the book before I watched the movie. The thing I know about the book, it was written and published by a white woman and it was told by the black women who were maids in the 1960s. It gave me some assumptions to go with. Before I start, everything that I will bring up are tightly about the movie and the book. It is like a little summary however the reviews I read are really good concerning the movie and the book. The movie was produced in a small town Jackson, Mississippi. Racial tension was so high at that time. The Black women worked not only as maids in that town, but they practically raised white people’s children too. So far, they were seen as “HELP” and were treated inappropriately and poorly. Skeeter, is a young woman who were living in that town. She gets the idea to write a story about these women who were maids, because of her good experience with the black woman who raised her and took really good care of her when her mother was not around. I really liked and enjoyed this movie. It got my attention and made me cry couple of times while watching some parts. What was so interesting and good about this movie? At the beginning of the movie, the acting was excellent. Viola Davis who played a maid named (Aibileen), she is an amazing woman who was one of the central characters in the movie...
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...Understanding your company review process Your company determines the review process to use to meet its business goals. A review process can be anything from an annual performance appraisal to an all-encompassing performance management policy that includes development, compensation, and succession plans. No matter what process your company uses, all review processes have a lifecycle. A lifecycle is the sum of all the phases that make up your company’s review process from start to finish. Typically, one phase flows into another until the process is complete. For example, a general lifecycle might include four main phases that flow as follows: ◾1 : The initial Planning Phase at the beginning of the fiscal year that allows a manager and employee to determine what content to include in the performance appraisal form. ◾2 : Followed in a few months by a Progress Check Phase where the manager and the employee meet to touch-base on their progress to date. ◾3 : Followed in another few months by the Assessment Phase, in which the manager and employee use the appraisal form to evaluate the employee based on the exhibited accomplishments of the year. ◾ 4 : Followed by the final Analysis Phase, in which the manager determines the reward and compensation based on data gathered during the Assessment Phase. How SuccessFactors fits into your company review process SuccessFactors is designed to work with your company's review process, with the review process as the focal...
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...Thinking, Reading and Writing Critically In order to get the highest possible grades in a subject assessed in writing you need to be able to demonstrate an ability to think critically about the sources of information (text-books, academic papers, academic websites and the like) that you use in the construction your answer. You must, in other words, do more than simply take information from other sources and use it construct an answer. It is not enough to select some apposite quotations and demonstrate in that way that you have read around a subject widely and found some pertinent sources of supporting information. To get the highest grades you must be able to replicate a professional academic’s ability to critically assess the academic work of other, published authors. Many professional academics are capable of doing this because over the course of a career they have read an enormous number of text-books and papers in a subject area and, as a result, possess and have mastered a large body of knowledge that they can use to critically assess any new work they encounter. Indeed, for such academics the process of reading critically may have become almost entirely subconscious. As they read a new paper in their subject area they cannot stop their brains from critically comparing the new information with the knowledge they already possess. Clearly, as students, you do not yet possess such an extensive body of knowledge, nor can you hope to acquire one quickly enough to apply...
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...A Review of Literature Related to Oil Spill Dispersants 1997-2008 for Prince William Sound Regional Citizens’ Advisory Council (PWSRCAC) Anchorage, Alaska by Merv Fingas Spill Science Edmonton, Alberta PWSRCAC Contract Number - 955.08.03 Disclaimer: The opinions expressed in this PWSRCAC-commissioned report are not necessarily those of PWSRCAC September, 2008 ii Abstract This report is a review of the literature on oil spill dispersants published from 1997 to August, 2008. The report identifies and focusses on recent advances in dispersant effectiveness, toxicity, and biodegradation. Other topics such as application, use, behaviour and fate are also covered. The prime motivation for using dispersants is to reduce the impact of oil on shorelines, thus the application must be successful and effectiveness high. As some oil would come ashore, discussion remains on what effectiveness is required to significantly reduce the shoreline impact. A major issue is the actual effectiveness during spills so that these values can be used in estimates for the future. The second motivation for using dispersants is to reduce the impact on birds and mammals on the water surface. The benefits of using dispersants to reduce impacts on wildlife still remain unknown. The third motivation for using dispersants is to promote the biodegradation of oil in the water column. The effect of dispersants on biodegradation is still a matter of dispute. Some papers state that dispersants inhibit...
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...Book Proposal We would like to consider your book for our publishing programme on the basis of the publishing proposal that you submit to us. The more information you provide, the more easily we can assess your ideas and the planned book. The proposal is a crucial first stage towards publication, and the following guidelines and form are designed to help you present the key areas of your proposal in the most effective manner possible. Introduction 1. Proposed title and subtitle. 2. Author’s/authors’ name & title, work address, e-mail address and telephone no. Educational 3. Is the book meant for University/ College of Further & Higher Education/Library and is it a Reference/Course Text/Advanced Academic Book? 4. If the book is for a course, please give the name of the course title(s) & level, the year, the dept, the enrolment, the name of current text(s) and it (their) publisher(s). Do you teach such a course? If yes, please list the course name, institution, level and enrolment. 5. Is the book likely to be adopted as compulsory purchase for the course/recommended purchase (i.e. reference text besides main text)/recommended for reference or further reading /an original contribution to the field? 5. Would you consider this book to be an original contribution to the field? The Competition 7. What are the most comparable existing books? Please name the author, title, publisher, publication year, page count and price. 8. How...
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...Review of World Investment Report MGX5966 International business theory and practice Lecture time: 18:00-19:30, Tuesday Lecturer: Quamrul Alam Tutorial time: 12:00-13:30, Tuesday Tutor: Sharif Rasel Due date: 09/09/2014 Students: RUIHAN FAN (26297701) Review of World Investment Report 1. Introduction This review is going to talk about the recent trends discussed in the WIR 2014, the reason that developing and emerging economies have attracted FDI, and why will SDGs have a significant resource implication for future investment decisions of MNEs. 2. The recent trends discussed in the WIR 2014 1. Global FDI flows Global FDI flows increased by 9 percent in 2013 to $1.45 trillion, up from $1.33 trillion in 2012. Although the share of developed economies in total global FDI flows remained low, it is expected to rise over the next three years to 52 per cent. Global inward FDI stock rose by 9 per cent, reaching $25.5 trillion. It reflects the rise of FDI inflows and strong performance of the stock markets in many parts of the world. 2. FDI inflows FDI inflows rose 9 percent in 2013 revealed a moderate pickup in global economic growth and some large cross-border M&A transactions. The increase of FDI inflows was widespread in all major economic groupings − developed, developing, and transition economies. Developed countries’ FDI inflows grew by 9 percent, reaching $566 billion. Developing economies reached a new high of $778 billion, accounting...
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...Review on the hunger games It's a true shot to the heart! “The Hunger Games,” the highly anticipated movie based on the best-selling teen novel, is as tough-spirited as fans would hope for — and exciting and thought-provoking in a way few adventure dramas ever are. It’s also a far more serious movie than the marketing, and mainstream mania, have led us to believe. It’s better and scarier than its source book, and aims an angry eye at our bloodthirsty, watch-anything-and-cheer culture.And there’s also pro-rebellion, anti-1% sentiment coursing through its blood. While the dark allegory within Suzanne Collins’ 2008 publishing phenomenon remains intact, it’s anchored by a remarkable performance from Lawrence, as everyone now knows, plays Katniss Everdeen, a 16-year-old in a future North America reconfigured after war and eco-disaster into “Panem.” A dozen impoverished “districts,” controlled by the amoral Capitol, make up the ex-U.S. Katniss’ family lives in District 12, formerly Appalachia. She and her friend Gale (Liam Hemsworth) hunt for squirrels to survive — her preferred weapon is a bow and arrow — while hoping not to hear their names called in the Hunger Games, in which a young girl and boy from each district are picked by lottery for an annual, televised death match — killing each other for the amusement of the wealthy and powerful.The Games are a way of punishing constituents for a nearly century-old uprising, though haunting propaganda films paint them as honorable...
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...FILM REVIEW 'THE YOUNG VICTORIA' «THE YOUNG VICTORIA» is a historical drama about the first few years of the Queen Victoria’s long reign in England during the 1800s, including her relationship with the object of her affection, her husband Prince Albert of Germany. The film is exciting. If you like this sort of film- you will not be sorry you saw it. Director Jean-Marc Vallee won several awards for his last film C.R.A.Z.Y., but The Young Victoria is probably enough to get him into the mainstream. His work with cinematographer Hagen Bogdanski (who worked on The Lives Of Others) is very good. There are a number of excellent performances: Jim Broadbent as the jovial and jaded King William; Jeanette Hain as the Baroness Lehzen, Victoria's former governess and confidante; Paul Bettany as Victoria's first Prime Minister, Lord Melbourne, and Michael Maloney as his successor Sir John Peel are also very good. Despite her youth, Victoria (Emily Blunt) has become increasingly aware of the critical position she holds. As the only legitimate offspring to be produced from three aging brothers entitled to the British throne, she stands next in line to wear the crown. Nor is she blind to the ambitious intentions of the people around her especially her mother, The Duchess of Kent (Miranda Richardson), and her advisor Sir John Conroy (Mark Strong). With the present monarch’s health failing, the Duchess and her right-hand-man are putting pressure on the naive...
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...Abstract: Agile methods in recent years have emerged as a new paradigm in software development, which promises to address some of the problem areas of traditional approaches by freeing some of its constraints. In an attempt to produce an improvised process to designing and implementation and thereby to produce qualitative deliverables, several pioneering efforts have been suggested. This paper examines two such methodologies that promote agility: eXtreme Programming and SCRUM. The process, the values and principles of the XP and SCRUM are described in detail. Crucial feature differences between XP and SCRUM and the advantages and disadvantages of both methodologies are also discussed. Keywords— XP, SCRUM, Agile INTRODUCTION The software development industry has been evolved to become the most important industries of time. This industry employs many practitioners world wide to create the most essential products that is been used to extend our lifestyles. From controlling the production of food we eat to providing safety and control of the vehicles, software has become the embodiment of the world's most valuable intellectual property.[15] In last few years, the trend to more agile has been the most significant event we have seen since the application of traditional software development process. The agile software methods and development is practices based approach which is empowered with values, principles and practices which make the I. software development process more easy...
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...Purpose of the study In response to the growing need for moral accountants who possess ethical and reflective qualities; an ethics education program was developed based on ethics as a reflective, critical capacity. This paper aims to describe the impact of the program on reporting behavior. In the abstract of this article it states that the purpose of this study is to examine the impact of an ethics education program on actual behavior rather than hypothetical situations using a quasi-experimental design with two student groups. A ‘quasi-experiment’ is an observational study in which the subjects to be observed are not randomly assigned to different groups in order to control the assignment to the treatment condition. Throughout the abstract and introduction, the researchers provided several arguments to establish the significance of their study. The main arguments were that honest reporting under anonymous conditions suggests that students have internalized ethical values toward honest reporting and that individuals who report honestly even when anonymous are more likely to have internalized ethical values toward honest reporting. The title of the article is strong and the research topic is valid; it clearly shows the purpose of the article is some kind of experiment or observation that discusses the impact of ethics education in regards to reporting information. The article effectively discusses the need for more ethical accountants when it cites previous articles from Desplaces...
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...HIS 122 February 27, 201 Cliff Tyndall: Instructor Felicia Mitchell A Review of “The Shock of War” By the end of World War One the British Army had dealt with thousands and thousands of cases with shell shock. The article explores how the army tackled this extreme trauma, and how it was regarded by those back home. Shell Shock was a term used during the First World War to describe the psychological trauma suffered by men serving on the war's key battlefronts. The intensity of the essentially artillery battles fought along these war fronts. It often caused neurotic cracks to appear in otherwise mentally stable soldiers. Men who saw service of any great length on an active front quickly came to recognize the symptoms of shell shock among their fellow men. Recognition in the form of military authority was rather slower to develop. At first shell shock victims were believed to be suffering from the direct physical effects of shell blasts or toxic exposure. Symptoms varied widely in intensity, ranging from moderate panic attacks. Which sometimes caused men to flee the battlefield: a crime which was invariably regarded as rank cowardice and which resulted in a court martial for desertion to effective mental and physical paralysis. Sent home to recover, many shell shock victims recovered over time, whereas many others continued to feel its effects for years afterwards. Treatment for shell shock was primitive at best and dangerous at worst; psychological theories governing its...
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...REVIEW WEEK 10: Pop Culture in Indonesia Pop culture has been penetrating the Indonesian culture in past few years. Islamic culture such as wearing veil for the women is a very common view in universities. In Universitas Gadjah Mada, there are 3 types of women who wear jilbab or veil. The first type is the one whose body, face, legs are fully covered except for their eyes. They basically can be called as cadar women. These veiled-women are known to not interact with boys and hangout after classes, but going home immediately. They are usually closed and don’t listen to music at all or watch television, and only read from paper. They usually focus on their study. And most people sometimes referred the cadar women as terrorist wife or family. The second type is the student with long veils, long skirts and socks. These women wearing long veil is usually very active in religious activity and organization. They don’t interact with boys if they don’t need it. But their view to the girls who are not wearing hijab or wearing it in a trendy way still stiff. They think that by not wearing it properly it gives Islam a bad image. These people only hang around with oens who are wearing long veils. And their ways (women) for finding a husband is very weird. The women usually received a CV from the men who want to marry her. The women can select and choose the men they want. Most parents are afraid when their daughter started wearing long veil they become too fanatic. The third one is the girls...
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...Review Sheet for Test 1 Marketing Chapter 1: Define Marketing: “All the Business activities needed to get goods and services from produce to consumer. 3 Eras of Marketing: * Production Era: * Sales Era (1946): * Concept Era (1957): Societal Marketing Concept: Trying to come up with a product that is god for society. Define a Market: People, Money, Need, Authority to buy, Enough to get a return on investment, Availability to consumers. Chapter 2: Define Strategic Planning: “Where do we want to be next year, how do we get there?” SWOT Analysis: Analyzing the Strengths, weaknesses, opportunities and threats Mission Statement: How you portray your goal to the public Portfolio Analysis: Strategic Business Units: Smaller entity businesses under an umbrella company. BCG Matrix: Cash Cow, Star, Question Mark, Dog Product to Market Expansion grid: * Existing, Existing= Market penetration * Existing, New = Market Development * New, Existing = Product development * New, New = Diversification Marketing Mix: The 4 P’s * Product * Price * Promotion * Place Define Positioning: The way by which the marketers attempt to create a distinct impression in the customer's mind Chapter 3: Environmental scanning: Looking into what factors can hurt your business - Macro: indirect effect a. Demography: Study of human population change b. Geography c. Education: d. Diversity e. Economy - Micro: Direct effect a. Work Force ...
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