Marketing Research on Reynolds Pen Essay Example for Free

Marketing Research on Reynolds Pen Essay We are deeply indebted to Ms. Malvika Mago for her constant support guidance and inspiration in completion of the program and preparation of this document. Our sincere thanks for giving me invaluable suggestion. We are also grateful to other employee of reynolds pen for their encouragement and help. We would like to express our sincere gratitude to reynolds for giving us an opportunity to complete our project. last but not the least; we would like to thank our parents and friends for their moral support throughout the project. Pens introduced to India, international quality writing instruments, and marketed them under the brand name Reynolds. It was also he first company to build a brand in a category that behaved more like a commodity till then. Over the last 20 years, G. M. Pens has invested substantially in building a large manufacturing base with facilities in Chennai and Pondicherry. A state of the art RD facility, one of the most sophisticated in the Reynolds family worldwide, has ensured that the latest in writing technology is available to the Indian consumers. G. M. Pens offers the widest range of writing instruments and accessories in the Indian market. A variety of writing instruments including ball pens, gel pens, fountain ens, mechanical pencils, markers, handy boards and childrens colouring pens that cater to consumers from the age group of six to sixty are marketed under the brand name Reynolds. A continuous focus on consistent quality and a constant endeavour to provide quality products at affordable prices have ensured that Reynolds has been the numero uno in the Indian writing instruments market. A substantial investment has also been made in establishing the Reynolds brand name through the mass media, especially through television and press ads, in an effort to convert the category from a commodity to a brand dominated one. The companys products are available in three hundred thousand retail outlets across India covered through a network consisting of 1800 redistribution stockiest and 27 main stockiest. This is facilitated by a sales and marketing team of over 300 professionals. Established in 1927 at la Ferte-Milon in France, Reynolds has over the past eight decades been a leader in writing instruments in Europe and the rest of the world. In 1946, the headquarters and factory were shifted to Valence, in the south of France. The company is headquartered at Valence till date. With 450 employees, Reynolds, France has a daily production of 4 million writing instruments. Of this, exports account for 50% of sales. It has a worldwide market presence in 80 countries around the globe. Reynolds has 12 of its own manufacturing units established in Africa, Asia and the Middle East. The year 1999 was a landmark year in the history of Reynolds. Since then it has been a member company of Sanford Corporation, USA. Sanford is a US $ 1. 2 billion company. Sanford is in turn the writing instruments division of the US $ 7 billion Newell Rubbermaid group. Sanford has the broadest range of writing, arking, coloring and drawing products worldwide.The main objective of our project is to know why the sales of Reynolds pen have declined so drastically and what are the reasons behind this . To know reasons behind this we did exploratory research to know- Why the consumers have switched to other company products. What is the defect in product. 0 Assess the current market share of Reynolds pen. 0 Is there any problem in design of pen. 0 Is there any problem in creating awareness about product The factors which are affecting our research design are Qualitative and Quantitative actors. To know this we will conduct Qualitative research first because we want to know why the sales of Reynolds pen has been declining and secondly we will conduct Quantitative research to know what are the reasons behind this. The type of research used for our study was an exploratory research, as the objective of the research was to have in depth understanding what are the reasons why the sales of Reynolds pen has been declining continuously . We have started our research. However we covered a specific list of topics and sub areas. This was done in the form of close ended question, where the timing, exact wording and time allocated to each question area was left at the interviewers. Since the research was qualitative as well as quantitative more emphasis has to be given while collecting data. Discretion open structure ensured that inspected facts or data could peruse easily. Mode of Interviewing: In research we have done face to face interview Sampling:- It consists of primary data and secondary data. Primary data was collected by applying probability. Under Non-probability we will use Convenience Sampling because we have to collect data from college going students . Where as secondary data was obtained by seeing past sales records of Reynolds pen, magazines, newspapers and by various other methods. Sample size:- We have selected sample of 100 college going students . We have kept our sample size small so that we may collect data accurately with precession. If we would have elected large sample size it would have become difficult for us to collect data.

Examine the contradictions in The Great Gatsby, including its narrative

Examine the contradictions in The Great Gatsby, including its narrative styles. The novel moves on two levels: Fitzgerald makes you see the magic and romance of Gatsby's vision of ideal love, dazzling the eye with wealth; yet, at the same time, the narrator pulls us down to earth revealing the immorality, waste and corruption of those who surround Gatsby and cause his death. Examine the contradictions in The Great Gatsby, including its narrative styles. One of Fitzgerald's main aims is to show the reader that the world he illustrates in The Great Gatsby includes both dazzling wealth and corruption, both of which are evident in American society of the 1920s. These work in parallel and come together as part of the same society: the wealthy upper class. Straight away we see this as being a contradiction, as the glittering surface impression of these wealthy people conceals their true nature as an immoral, careless and unsympathetic society. This novel clearly does move on two levels. The author enables us to look into the different worlds of money and romance (and whether or not they can exist together), as it is not only a story of superficial richness, but also of lost love and the use of wealth to regain it. These themes alone are a contrast, as money is a matter of the mind and love a matter of the heart. Although Fitzgerald glamorises the lifestyles of the rich minority, he also asks us to question how attractive money really is, by conveying to us the destruction and unhappiness that huge wealth can cause underneath its dazzling exterior. We are led through the various events of the novel by our narrator, Nick Carraway, who is also Gatsby's neighbour. Nick, despite being surrounded by e... ...atsby's eventual death. Daisy, by killing a woman in Gatsby's car, represents the fact that unmaterialistic people are often downtrodden by the wealthy. The rich themselves believe that money can buy them everything, including, as in Daisy's case, a guilt-free conscience. An underlying contradiction of the novel is that Gatsby's rich guests all thought that happiness rested in money, but the truth was that it does not, and never will. For Gatsby, the source of his happiness rested in love, and whilst the rich minority took everything, including love, for granted, Gatsby never did, and it proved to be his demise. The novel's biggest contradiction shows that although love is the source of life, in this instance it has killed a man in his quest to find it. Kate Cockburn Bibliography: 'The Great Gatsby', F.Scott Fitzgerald (Penguin Modern Classics).

A Condition Previously Known As Mental Retardation Education Essay

IntroductionIntellectual disablement ( ID ) , a status antecedently known as mental deceleration, is defined as a disablement characterized by important restrictions both in rational operation and in adaptative behaviour as expressed in conceptual, societal, and practical adaptive accomplishments and that the footing for the disablement has been present prior to age 18 ( AAIDD, 2002 ) . This status affects about 1 % of population ( Bello, Goharpey, Crewther & A ; Crewther, 2008 ) , and has historically been defined as an intelligence quotient ( IQ ) mark of less than 70 ( Schalock & A ; Luckasson, 2004 ) . In recent decennaries, the definition of ID has been revised, which now includes both a step of rational operation and an indicant of persons ‘ adaptative behaviour in their environment. Intelligence refers to individual ‘s overall mental ability or his/her capacity to ground, program, work out jobs, comprehend complex thoughts, and learn ( AAIDD, 2010 ) . The appraisal of rational operation is typically achieved through disposal of intelligence quotient ( IQ ) trial. Most IQ trials are structured in the manner that a mark of 100 is considered mean, with a standard divergence of 15 ( Hourcade, 2002 ) . In agreement to American Association on Intellectual and Developmental Disabilities ( AAIDD ) guideline, an rational degree that is considered to be within the scope of rational disablement if it is two or more standard divergences ( SDs ) below the mean ( AAIDD, 2002 ) . In other word, a degree of 70 IQ points or lower will be the cut-off point for ID when utilizing an IQ trial with a mean of 100 and a standard divergence ( SD ) of 15, which account for the lowest hiting 2 % of the normal population ( Flynn, 2000 ) . Adaptive behaviour refers to the aggregations of conceptual, societal, and practical accomplishments that people learn and perform in their mundane lives ( AAIDD, 2002 ) . Similar to the appraisal of rational operation, adaptative behaviour are assessed with instruments which requires detecting the person in state of affairss where these accomplishments are required, or questioning those who know the single well ( Hourcade, 2002 ) . In AAIDD web site, important restrictions in adaptative behaviour are operationally defined as public presentation that is at least two standard divergences below the mean of either ( a ) one of the undermentioned three types of adaptative behaviour: conceptual, societal, or practical, or ( B ) an overall mark on a standardised step of conceptual, societal, and practical accomplishments. In general, persons with ID possess some common features. Typically, persons with ID will larn and develop more easy than a typical individual because of their cognitive restrictions. More frequently, they present with specific it cognitive shortages such as damage in memory, attending, or comprehension of linguistic communication, which frequently result in their lupus erythematosus efficient larning abilities ( Hourcade, 2002 ; Van der Molen, Van Luit, Jongmans, & A ; Van der Molen, 2007 ) . To certain extend, their slower processing, restricted memory or attending can besides associate to their lack in ego control and ordinance, ensuing in feelings that they are more inactive or disengaged from activity ( Linn, Goodman, & A ; Lender, 2000 ) or and more distractible or unprompted than others ( Goodman & A ; Linn, 2003 ) . Therefore, persons with ID frequently require different signifiers and grade of support in the procedure of larning and development.Identification/Diagnosis of ID The standards used for designation and diagnosing of ID have evolved from a long manner. Schalock and Luckasson ( 2004 ) sum up four attacks that have been used to place individuals with ID historically. In the early twenty-four hours, ID was ab initio identifies non establishing on rigorous standards, but on persons ‘ inability to accommodate to their societal environments. The rise of medical theoretical account nevertheless has changed the attack of placing ID. In term, the base of designation was shifted to the individual ‘s symptoms complex and clinical syndromes, with the focal point on the functions of physical causes and heredity. Later, with the rise of psychometric trials, the standard for designation and diagnosing of ID was once more shifted to individual ‘s rational operation. In term, steps obtained from IQ trials are used as ways to specify and sort persons with ID and their badness of ID. The concluding displacement in the standard was to an attack they named as ‘dual-criterion ‘ , where both cognitive operation and adaptative behaviours were included as standards of specifying ID. The dual-criterion attack was foremost introduced by AAIDD ( was so named as AAMR American Association on Mental Retardation ) in 1956 and has been adopted by other diagnostic systems such as the International Classification of Functioning, Disability, and Health ( ICF ; World Health Organization ( WHO ) , 2001 ) , the Diagnostic and Statistical Manual of Mental Disorders 4th ed. , text rpm ( DSM-IV-TR ; American Psychiatric Association, 2000 ) , and the other clinical guidelines used for prevailing definitions of rational disablements such as the International Classification of Diseases, and Related Health Problems 10th alteration ( ICD-10 ; WHO, 1992 ) ( Schalock & A ; Luckasson, 2004 ) . The current dual-criterion attack of the categorization system besides present a paradigm displacement in the research and instruction pattern, where rational disablement is no longer be viewed as person-centered shortage, i.e. , feature of the persons. Rather, rational disablement is contextually determined and with appropriate supports, life operation of persons with rational disablement may better ( Schalock & A ; Luckasson, 2004 ) . With that, the current AAIDD categorization system emphasizes the importance of contextual support and intercession to turn toing restrictions in the countries of rational and adaptative operation. The AAIDD categorization system is one of the most widely used diagnostic systems in the field of research and instruction designation ( Schalock & A ; Luckasson, 2004 ) . The working definition of ID proposed by AAIDD composes of three key constituents which are besides normally acknowledged by DSM IV-TR and ICF ; 1 ) an IQ mark of less than 70 ; 2 ) an important shortage in adaptative map and 3 ) the oncoming of disablement prior to 18 old ages of age. Within this system, the three required steps for a diagnosing of ID include an IQ trials, adaptative behaviour graduated tables, and documented age of oncoming.Designation of ID in clinical scenesThe term designation here refers to the procedure of appraisal and diagnosing which a formal diagnosing of ID can be arrived if standards are met. As mentioned above, internationally, clinical definitions of ID are normally based on established psychiatric diagnostic systems such as ICD-10, ICF and DSM-IV-TR. As noted by Salvador-Carulla and Bertelli ( 2008 ) , there is small variableness in the standards of the different psychiatric diagnostic systems. Besides turn toing on the age oncoming of the disablement, all these systems portion a common attack, Internet Explorer, the appraisal of the individual should be taken as a whole within the context of the individual ‘s rational capacities and adaptative operation in his environment. Nevertheless, minor differences are still present within some standard among the different diagnostic systems ( Salvador-Carulla & A ; Bertelli, 2008 ) . For case, the cut-off point of the IQ degree ( AAMR: 70-75 ; DSM-IV-TR: 70 ; ICD-10: 69 ) that classify persons as holding marginal rational disablement varies among the three major diagnostic systems. Furthermore, the definition of adaptative accomplishments differs among these systems ( Colmar, Maxwell & A ; Miller, 2006 ) .Designation of ID in educational scenesThe designation of pupils with rational disablement within educational puting evolves parallelly with the alterations in the clinical diagnostic systems of this disablement ( Smith, 1997 ) . Internationally, this revised definition of ID by AAIDD has influenced the development of new categorization system in educational scene. In term, the categorization of ID has moved from a simplistic IQ-based categorization system to a more holistic attack, where a three-step attack is normally accepted as the criterion of categorization ID and explicating support. Ee, Tan and Lim ( 2004 ) sum up the stairss as follow ; 1 ) a formal appraisal of IQ and adaptative map ; 2 ) an analysis of persons in the four dimensions of rational operation and adaptative accomplishments, psychosocial and emotional consideration, physical wellness and etiology, and environmental consideration ; 3 ) depict the profile and strengths of support needed based on the profile. Although the above mentioned system has been acknowledged as a new subject for designation of ID in instruction system, there are still fluctuations in the accent and procedure of placing ID in educational scenes among states. Colmer, Maxwell and Miller ( 2006 ) remark that phenomena such as over-emphasis on IQ mark and concentrating on disablement are still prevailing in educational scenes where cognitive ability is frequently perceived as the base of person ‘s attainment. In Singapore, the guideline for designation of ID is mostly consistent with the diagnostic system of World Health Organization ( WHO ) ( NCSS, 2003 ) , where a formal appraisal of adaptative operation and IQ are necessary when finding the degree of restriction and support needed, with a prevailing inclination to adhere to the traditional categorization system, where the degree of disablement is associated with IQ tonss ( Ee, Tan & A ; Lim, 2004 ) .Educational Placement of pupils with IDThe arrangement of pup ils with ID can be classified into three chief scenes ; viz. mainstream school, particular schools and exterior of the instruction system, i.e. , drop-outs ( Snell, Luckasson, Borthwick-Duffy & A ; et Al, 2009 ) . Snell, Luckasson, Borthwick-Duffy and et Al, ( 2009 ) describe the national tendencies of arrangement for pupils with ID in the USA. Although inclusion pattern has been advocated in the last decennary of twentieth century in the USA, there are still about 50 % of pupils who are diagnosed with ID receive their instructions in separate scene such as particular schools. In add-on, a important proportion of pupils with ID leave school earlier. Cited in Snell, Luckasson, Borthwick-Duffy and et Al, ( 2009 ) , Polloway et Al. ( 2009 ) reported that in the USA, 28.6 % of pupils with rational disablements drop out form schools during the 2002-2003 school twelvemonth. Overall, the per centum of pupils with ID who are to the full included in mainstream schools is still comparatively low, accounted about 11 % in the USA ( Snell, Luckasson, Borthwick-Duffy & A ; et Al, 2009 ) . In Singapore, kids with ID are placed in both particular and mainstream schools, depending on their abilities and demands. Typically, Children with profound disablements and require extended support are enrolled in particular schools, and kids with milder disablements can be found in all degrees of educational systems ( Lim & A ; Nam, 2000 ) . The procedure of appraisal and designation of ID in educational scene is frequently motivated and guided by a primary end of enabling a sound educational arrangement. Traditionally, kids with rational disablements are normally enrolled in particular instruction schools ( MacMillan & A ; Forness, 1998 ) . With the rise of inclusion motion, the educational arrangement of kids with ID varies among states. In Singapore, kids with rational disablements, including those at mild degree are by and large enrolled in particular schools, in which most of them continue and complete their instructions within the particular instruction system ( Ee, Tan & A ; Lim, 2004 ) . Whilst in states such as the USA, where inclusion pattern has started for more than a decennary, more pupils with ID are analyzing in mainstream schools. Based on estimated prevalence rates, it is suspected a ample figure of kids with ID are enrolled in mainstream school ( Ee, Tan & A ; lim, 2004 )Screening of IDIt is recognized that planning and intercession for individualised support for persons with ID are indispensable in the current epoch. In order to program and measure the effectual and rightness of the support service, valid showing and preliminary designation are necessary to ease a formal referral and appraisal, therefore support and intercession. Nevertheless, in contrast to the considerable understanding among professional pedagogues and clinicians as to which guidelines and processs to follow in naming rational disablement, there is no consensus on the formal processs to test ID ( MacMillan & A ; Forness, 1998 ) . As cited in MacMillan and Forness ( 1998 ) , in the USA, most of the pupils with ID are foremost screened and referred by their instructors for formal designation of ID by mental wellness professionals. Similarl y, in Singapore, no formal processs are available when come into the showing of ID. The informal showings of pupils with possible rational disablements are normally done by school instructors. In fact, the procedure of referral for a formal appraisal and diagnosing frequently starts with instructor ‘s observation on pupils ‘ clear and consistent underachievement in their academic work ( Ee, Tan & A ; Lim, 2004 ) . In other word, due to missing of formal guidelines for testing procedure, instructors ‘ cognition and judgement on the pupils ‘ abilities play important functions in the referral and designation procedure. Teachers played a cardinal function in the designation of pupils with particular educational demands and in specifying the degree of support ( LOS ) they required for each pupil ( McKinnon & A ; Cordon, 1998 ) The grounds are described as follow ; foremost, since instructors normally refer pupils after they realize that pupils ‘ public presentations are significantly below the norm. The ‘norm ‘ , i.e. , mean public presentation of the pupil ‘s immediate equals becomes the benchmark for instructors to do determinations for referral. In term, a underachieving pupils will be more likely referred for formal appraisal if he is in a category or school with high-achieving equals, and otherwise less likely to be referred if all his schoolmates are low-achieving. Second, the instructors ‘ relevant cognition on ID and particular demands is besides important in the procedure of testing without a formal showing tool ( MacMillan & A ; Forness, 1998 ) . In such instance, who get referred varies from schoolroom to classroom as some instructors may hold higher tolerance working with academic-weak pupils, and others may hold small capableness in covering with those with troubl e to maintain up with school course of study. The ‘teachers factors ‘ in the procedure of testing for ID and particular demands are even evidenced in X school, where most of pupils are academic under-achievers, with co morbid behavioural and emotional troubles. A determination for referral is frequently less distinct when there are multiple jobs are naming for attending. Therefore, a standardised showing tool may supply a common metric for instructors to establish on when placing pupils necessitating formal appraisal and particular demands. In line with current diagnostic system, a testing tool with focal point on both cognitive ability and adaptative behaviours is necessary when come to a determination for support and arrangement.InclusionThe term inclusion here refers to a pattern that pupils with disablements are integrated into general instruction schoolrooms ( Quah, 2004 ) . In inclusive instruction, persons with disablements study full-time in general instruction schoolrooms. However, necessary supports may be given during their procedure of survey in general instruction schoolrooms ( Quah, 2004 ) . Since the late twentieth century, inclusive instruction has become an international tendency and docket ( Ainscow, Booth & A ; Dyson, 2006 ) . Policies and statute law have been passed in many parts of the universe to advance inclusion in instruction ( Booth, 1999 ; Bricker, 2000 ; Harris & A ; Stephenson, 2003 ; Ainscow, Booth & A ; Dyson, 2006 ) . In response to the displacement in statute law in particular instruction, ( grounds ofmore inclusion of ID in other states ) Inclusion of Down ‘s syndrome in mainstream school is widely accepted in England after more than 20 old ages of inclusion run ( Booth, 1996 ) . Snell, et Al ( 2009 ) more ID pupils are included in regular schools However, non in Singapore, As pointed out by Lim and Nam ( 2000 ) , in Singapore, a double instruction system providing to pupils with and without disablements is still runing. ( Due to miss of preparation for instructors ) Movement towards incorporating pupils with disablements, particularly those with moderate to terrible degree of disablements into regular schools remains slow. Teachers still refer their pupils with ID to particular schools Integrated instruction is an earlier version and refers to giving excess support to pupils with particular demands who are take parting in the mainstream course of study without major restructuring of content or bringing ( Booth, 1996 ) . . However, the tendency of inclusion has besides been accepted by society and school forces. Programs and services have been put frontward to ease the inclusion of pupils with physical disablements and autism ( Lim & A ; Nam, 2000 ) . ( Add more from LIM and NAM ) Although inclusive instruction is accepted as an international tendency for persons with disablements, surveies have revealed assorted consequences of benefits and jobs. Harmonizing to Wong ( 2002 ) , research surveies on inclusive instruction by and large suggest an betterment in societal accomplishments and community integrating after arrangement in mainstream school. Whilst, there are besides concerns that inclusion was damaging to run intoing the demands of some pupils if the adaptation of course of study is non tally with their cognitive abilities. In his survey on parents ‘ perceptual experience on inclusion pattern in Hong Kong, Wong ( 2002 ) studies that pupils with disablements face enormous trouble in run intoing academic demands in school, which impose obstructions for their effectual acquisition. ( ? Benefit related to Severity of ID or degree of support needed )Multi-cultural issues in showing and designationThere is ever concern that cultural minorities are falsel y identified as being rational disable. In order to turn to this concern, MacMillon et Al, ( 1996, as cited in MacMillon and Forness, ( 1998 ) ) investigate the presence of systemic differences among referred Caucasian, Hispanic and African American pupils in California. Their findings suggested that the Verbal and Performance IQ of Caucasic pupils are higher than African American pupils, taking to a plausible decision that schools are unwilling to mistake in mentioning minority pupils.History of instruction for kids with ID in SingaporeLack of preparation on particular instruction among instructors

Exploration of expanded access of investigational products - Free Essay Example

Sample details Pages: 3 Words: 984 Downloads: 5 Date added: 2019/10/10 Did you like this example? Question 1 Should the public have a right to investigational treatment outside expanded access, defend your choice? Expanded access or the compassionate use refers to the outside usage of a clinical trial of an investigational medical product that is the medical product that has not been approved by the Food and Drug Administration FDA. Food and Drug Administration Expanded Access is legislation that aims at providing seriously ill patients who have exhausted the available treatments options and thus have no other comparable standard treatment option to gain access to biological agents and investigational drugs. FDA was enacted by the United States Congress to prohibit the sale of misbranded, mislabeled, or adulterated foods and drugs in interstate commerce. Don’t waste time! Our writers will create an original "Exploration of expanded access of investigational products" essay for you Create order According to the author’s opinion, the public should have a right to investigational treatment outside expanded access. Some patients are not eligible for clinical trials and thus outside expanded access can lead to major inventions of medical products. Ordinarily, investigational drugs may be used under controlled trial. Investigational medical products to be used by a patient as part of the clinical trial is preferable since the trial can generate crucial data that may lead to the approval of medical products; a good example is the case of Josh Hardy (Kroll, 2015). Patients with no ongoing clinical trials or are not eligible for any clinical trials can receive the medical product through expanded access when appropriate. As much as the public have the right to investigational drugs, they should strive to balance between the need and patient safety. The right to investigational treatment outside expanded access can lead to the invention of medical products useful for healing rare diseases with no treatment options as the same time can be dangerous to the patients’ health (Mahady, 2015). That is why the balance between patient safety and need should be emphasized. There has been a lot of conflict between FDA and the Abigail Alliance about when is a drug safe for use. Abigail Alliance blames FDA by saying that it should make drugs accessible on the first stage of development. Each person, if she or he shows the willingness   to undertake investigational treatment outside expanded access should be allowed to do so under close check by a highly qualified physician (â€Å"Food and Drug Administration,† 2016). Question 2 What are the implications of expanded access on drug development from the pharma and FDA perspective? Abigail Alliance claims that FDA makes drugs available for terminally ill patients at early stages of testing. The FDA perception on implications of expanded access on drug development is that it can lead to more useful data that may lead approval of the medical products and their improvement. FDA has facilitated access to investigational drugs to treat patients with serious and immediately life-threatening diseases or conditions with no therapeutic alternatives. Expanded access programs are majorly restricted to patients ailing from serious or life-threatening diseases and have exhausted all standard treatment options and are not eligible to enroll in clinical trials since they don’t meet the inclusion criteria. Pharma companies supply investigational drugs at no cost. This is likely to result in financial issues that are likely to face pharmaceutical companies. Pharma has the perception that supply of unapproved drugs can lead to legal acts being taken against them. The pharma and the FDA have in mind that the drug administered for trial and research purposes can benefit some patients, others experience no effect, and some patients can be harmed by the drug. The pharma and the physicians are faced with difficulties when prescribing drugs that are to be used for the first time. Therefore, from fear of overdose they may prescribe less dosage which has no impact on the ailing patients when the same medicine if properly prescribed could offer significant healing (Ross, 2009). Some patients can refuse to take drugs which have not yet been approved as safe for use. Expanded access gives crucial data that help weigh the benefits and risks of the medical product. Question 3 Are the FDA regulations and guidance in place for expanded access sufficient in both protecting the public’s safety and also addressing the ethical concern of allowing patients with severe or life-threatening diseases the option to have access to an investigational product where the benefits and risks are still being explored? FDA has outlined set of regulations and guidance that govern on how medical products under investigation are being administered to patients with severe, life-threatening conditions. FDA has these regulations in place to ensure a balance between benefits and risk that can be associated with investigational drugs (â€Å"Food and Drug Administration,† 2016). According to the opinion of the author, the FDA regulations and guidance set in place for expanded access are sufficient in protecting the public safety and addressing the ethical concerns of patients suffering from severe, life-threatening diseases. For example, the Abigail Alliance once send a proposal to the FDA   suggesting that drugs should be made available to the patients with severe, life-threatening illness for purchase after the earliest testing stage. The FDA declined the proposal, one of the FDA regulations and guidance require three to four stages of medical product testing before it can be sold to the public ( Jacobson Parmet, 2007). The act of rejecting the proposal from Abigail Alliance shows that FDA is committed to ensuring the safety of the public. It is more dangerous to make medical products under testing and research available to the public in its initial stages; this poses more risks as compared to the benefits. Making a drug available to the public at its first stage of development poses a great risk to the public safety. The drug can have great negative impacts than positive impacts and thus harm a large group of people since it is not under controlled testing. FDA rejecting Abigail Alliance proposal proves that its regulations and guidance is sufficient to protect the public and patients with severe life threatening illness.