The Use Of Fda Regulation Of Drug Industry And Its Impact...

INTRODUCTION Human drugs are regulated by the U.S Food and Drug Administration (FDA). One of the first legislation which authorized FDA to regulate drugs was â€Å"Pure Food and Drugs Act† enacted in 1906. In last century, role of FDA has significantly increased in terms of regulation and supervision of drugs to promote and protect public health. The historical evolution of FDA regulation of the drug industry and its impact on marketing unapproved drugs will be discussed later in this memorandum. The term â€Å"drug† is defined means â€Å"articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man† by â€Å"affecting the structure or any function of the body of man.† In order to be marketed, â€Å"new drug† needs to have an approved application. â€Å"New Drug† can be defined as â€Å"any drug†¦the composition of which is such that such drug is not â€Å"generally recognized as safe and effective† for their labelled use. Prescription drug are prescribed by a physician, usually bought at pharmacy, prescribed for and intended to be used by one person and regulated by FDA through the New Drug Application (NDA) process. A typical NDA approval process includes three clinical phases which are distinct in terms of number of patients, length of study and purpose. The new drug application approval process helps in maintaining certain safeguards such as drug safety, dosing, manufacturing quality control standards, review of ongoing clinical safety and efficacy data,Show MoreRelatedRegulatory Agency: Food and Drug Administration Essay1617 Words   |  7 PagesAgency: Food and Drug Administration Victoria Steele University of Phoenix Regulatory Agency: Food and Drug Administration The regulation of all areas of health care in The United States falls to The United States Department of Health and Human. One such area is the regulation on medications dispensed within the United States. The section of The United States Department of Health and Human Services responsible for regulation on medications is the Food and Drug Administration (FDA). WhereasRead MoreDifferent Applications For Small And Large Molecules1623 Words   |  7 Pagesand BLA. Why are there different applications for small and large molecules? A small molecule drug approval required a New Drug Application (NDA) because it covered under Federal Food Drug and cosmetic Act Section 505 while large molecule drug required a Biologics License Application (BLA) because it covered under Public Health Service Act Section 351. Compared with conventional small-molecule drugs, products derived from a biological source are structurally complex, large molecules and involvedRead MoreOrphan Drug Market Development And Manufacturing Of Products1622 Words   |  7 PagesOrphan drug which is a drug or biologic that treats a patient population of less than 200,000 within the United States. 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The design of the study is to determine the effects of the drug or device on humans including how it is absorbed, metabolized, and excreted. The investigation of a side effects also observed by an increasing the drug doses. Not all drugs are passing during this phase, but nearly 70% of experimental drugs pass during thisRead MoreEthical Issues Associated With Marketing And Advertising2384 Words   |  10 Pagessociety in general. Ethical issues associated with Marketing and Advertising: Ethical issues in marketing arise from conflicts of interest among parties doing business with each other. Ethical marketing efforts and decisions should meet the expectations of the various players in the marketing effort (Halbert Ingulli, 2012). Each party has its own expectation on how the business relationship is supposed to be. Advertisements are the most common marketing methods used by businesses. 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Several years later, physicians began to form a link between phocomelia, a birth deformity, and pregnant woman who ingested the German-created drug. That little white pill is known as Thalidomide. Staying in the market for almost six yearsRead MorePharmaCare essay3748 Words   |  15 Pagespharmaceutical companies grow in unprecedented size and strength. Due to the unprecedented growth the larger pharmaceutical companies have gained leverage and power in the prescription drug industry, but they lack innovation to market and they seek ways to help the business continu e to increase its profits. The pharmaceutical industry was once ethically sound and was a valuable player in the development of human health. However, overtime with the lack of innovation pharmaceutical companies are becoming an unethical

A Brief Note On Human Resource Management And The Philips...

HUMAN RESOURCE MANAGEMENT (4.707) ASSIGHNMENT ON HIRING PROCESS BY SALES MANAGER SUBMITTED BY SHAMANTH GOURISH BABU STUDENT ID: 20141895 E-MAIL: shamanthg1994@gmail.com WORD COUNT QUESTION 1- 1117 STREAM - 136 SUBMITTED TO - DR. BOB BEAVE DATE: 5 June 2015 INTRODUCTION I was working in Philips Company in India as a sales manager of the different types of the product and the Philips Company was founded in 1891 by Gerard Philips his father Frederik Philips they came with company as Philips co. in Netherland at Eindhoven after 5 years the young brother strengthened the Philips co by introducing the bulbs in a market within a few years the Philips company become a largest supply of bulbs and commercial talent in the world and it was industrial revolution and Philips research laboratory was established at 1914 and they started introduce the first innovation is x-ray and radio technology. Here we dealing with many products like sound and vision particularly televisions, home cinema sound, home audio, DJ equipment’s, Headphones, Digital audio and video and many other products and company providing the customer service which is the main component of business during the outlets and involving with the customer interaction. (http://www.philips.com/about/company/companyprofile.page, 2014) 1. A) KEY RESULTS AREA PERFORMANCE STANDARD CONTROL INFORMATION To increase a number of customers in overseas and local marketShow MoreRelatedThe Internet Of Information Technology3102 Words   |  13 Pagespart of new generation of information technology and known as an important stage of development â€Å"information† age. (Ashton, 2009). As the name suggest, IOT means the materials, objects, animals or people which are connected to the internet without human-computer interaction by sensors or other unique identifiers. (Rouse, 2014). 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A Moment in My Life Were I Was Proud of Myself free essay sample

A moment in my life where I was proud of myself happened around the summer I graduated from high school in 2007. When I had finally graduated I could finally take a break from school, go out of town for a few weeks, and get to kick back Like I wanted to. AAAS enjoying my summer like any other teen, and Just like another teen I realized Its now time for me to get a Job especially since I wasnt In any rush to go to college. Not to mention that I was the youngest out of three and the only boy so yes I was kind of spoiled. But that all had to stop now that I was out of high school as such as I hated to admit It.So I began to go Job hunting and one thing I always known about when it comes to finding a Job that It Is not easy. We will write a custom essay sample on A Moment in My Life Were I Was Proud of Myself or any similar topic specifically for you Do Not WasteYour Time HIRE WRITER Only 13.90 / page There would be times were I would go on the Internet and fill out some applications, and then there was other times were my step dad would take me. I would at least try to have him take me from place to place at least too to their times every two weeks. One of the places we tried was my sister worked at and it was fast food restaurant. When the time came for me to fill out the application you would think since my sister of all people work here that the job was in the bag.But boy was I wrong about that 2 weeks pass and I never hear from him. But that didnt stop me I was determined to get a job because like every other teen in the summer if I was going to do anything I would need some money in my pockets. So one week me and my step dad are driving still looking, and he remembers out of no were someone else who he knows in fast food. So I end up landing a job at a fast food restaurant called National Coney Island. And end the end Vive learned its really true when they say sometimes its not what you no its who you no.

The Strategic crisis management in tourism - Myassignmenthelp.Com

Question: Discuss aboutThe Strategic crisis management in tourism. Answer: Tourism Crisis and Disaster Management in the Asia-Pacific(Vol. 1). CABI. In todays world, the tourism industry is currently one of the major economically sound industries throughout the world. The industry currently is exposed and vulnerable in front of various disasters and crises. This is because the hotel and tourism industry immensely depends on various external factors like political situation, the environment, discretionary income, currency exchange rate and many more. It can be said that the success of tourism industry is directly associated with the ability to provide a safe and pleasant premises to the tourists. When elements of disasters and crises take place in hospitality and tourism industry, the local community and the tourists gets majorly affected. These undesired events divert the flows of the tourism from not only that particular area, but from the neighboring regions or from the country. Nowadays, the increasing number of crises and disasters that are negatively affecting the industry varies from human influenced to natural incidents. R ecently, it is seen that the global tourism has witnessed various crises including numerous attacks by the terrorists, economic instability, global recession, natural disasters and chemical or bio threats. There are various features that can be attributed to the disasters are generally applicable to various disasters and thus confusion may arise with shared overlaps between the two, where crisis might occur as a unswerving result of a disaster. These two particular terms can be used interchangeably and can be acknowledged that the in between the boundary among human induced and natural behavior is blurred. The major difference between disaster and crisis can be attributed to the organization itself, or it can also be explained as something that originated from outside the organization. the particular term crisis explains the situation where the main reason behind an event is somewhat self-inflected by such issues as inept management structures and practices to adapt to changes. On t he other hand, disaster can be explained as a situation where an organization is confronted with some catastrophic changes over which it has some control. In this regard, it can also be said that in most cases crisis originates from lack of planning by the management of the organization and thus it can be surely anticipated. On the other hand, disaster is the generally responded to after an event, or when human involvement can be reactive. Conceptualizing organizational resilience in tourism crisis management.Tourism crisis and disaster management in the Asia-Pacific,1, p.15. Organizational resilience rightly addresses the requirement of the organizations to fight the disruptions regarding contemporary disaster and crisis ridden environment. On the other hand, it can be said that Organizational resilience is the capability of the organizations to survive the crises. In this context, it is worth mentioning that that resilience actually determines the ability of the system of the tourism organization to absorb various shocks and changes; and stability can be explained as the capacity of the systems to return to a state if symmetry or equilibrium following the elements of disturbance. Various studies proved that communities depend on the tourism and hospitality organizations to plan, respond to and recover from various disturbances in order to incessantly host critical and luxury services. In accordance to early management theory, the tourism organizations were seemed to be relatively stable, but when a massive change in the environment was seen it was often seen as a coping with a steady change rather than with sudden changes that can test the institutions capability to cope. Thus, it can be said that the organizations are generally known to respond to various disruption and uncertainty in various ways while portraying varying levels of resilience. Since last decade, it has been seen that the disasters and crises has increased in an alarming rate in tourism and hospitality industry due to various reasons. The challenges originated from various disasters and crises have compelled the tourism organizations to manage the situation in a better and scientific way. The managements of these types of organizations should take precautions to fight these sorts of oddities in order to secure the lives of the employees and the visitors. In a competitive market, if the management of a tourism organization fails to secure the safety issues of the visitors, it would potentially ruin the tourism business of that particular region. Tourism risk and uncertainty: Theoretical reflections.Journal of Travel Research,54(3), pp.271-287. Analyzing the risks in tourism and hospitality industry is fragmented and uneven, it sheds light relatively narrowly on the risk factors as a set of negative results to be avoided by the individuals, organizations and destinations. The purpose of this journal is to highlight the sector specific systematic and unsystematic risk factors that are central to all types of tourism activities. A strong need for theoretical understanding regarding the various ideas regarding the risks and uncertainties in tourism; that engages with how these can be manifested in different other scales, and be analyzed from competing perspectives. The potential and contribution of both constructive and rationalist approach should be evaluated while keeping the focus on tourism organizations, individuals, destinations and intermediaries. This particular journal also identifies the scale-specific issues that range from decisions taken by the individuals to the securitization of various national policies. In tod ays world, it is important to secure the loopholes that can bring in several disasters and crises for the tourism organization along with the visitors and employees of the organizations. It is seen that in todays world, there are som much threats from the crises which are totally human induced and the managements of the tourism organizations should keep in mind that they need to have proper infrastructure and planning to try to prevent those unwanted incidents. Nowadays it is seen that due to unprofessionalism of some of the WHS team members, some undesired things take place and those are not at all justified. To fight these oddities, the managements of the tourism organizations should take proper actions to keep things in order and controllable. The managements of these organizations should deploy a team dedicated for the hazard and crisis management for best results. The team would get engaged in identifying and reporting the hazardous elements within the premises of the organizat ions; making it easier for the government to keep things in order. Thus it can be said that there are a lot of space for improvements in this regard worldwide and the managements of the tourism and hospitality organizations should stress on these factors. Strategic crisis management in tourism: An application of integrated risk management principles to the Croatian tourism industry. The strategic management of disasters and crises is seen as a major ingredient to manage a sustainable development for the tourism industry. The contemporary studies regarding this issue have highlighted various notions and agendas regarding the disasters and crises management in tourism industry. In todays world, this topic has gained much attention because of the undesired events that took place earlier, like beach massacre in Port El Kantaoui, steady rise and destructive activities of terrorist groups and above all reluctance of individuals to make a secured stress management plan for the industry. Nowadays the governments of many countries are making new policies in this regard, compelling the managements of tourism organizations to take proper actions to prevent and effectively manage disastrous events within the premises of the organization. The present scenario does not permit the managements to show any kinds of reluctance in this regard as that can potentially endanger the l ives of innumerable individuals at a stretch. It is a matter of fact that currently in this ever-changing world, the tourism industry is facing immense challenges and threats that leads to extreme situations, crises and emergency. Therefore, these types of disasters are leaving a long lasting impact on the tourism industry and potentially reducing the revenues generated from tourism and hospitality business. Thus in recent years studies regarding this issue have gained immense popularity. It has been noticed that due to various terrorist attacks, the industry is facing some huge challenges and that is ruining the profitability of the industry and that is making the situation concerning. The managements of the tourism and hospitality organizations thus should spend some time and money to make the security system better and effective so that they at least prevent the damages to some extent. There should be proper procedure to measure the level of performance of the team members of the Crisis management team of the tourism organizations. the managements should incessantly try to improve the security systems in order to avoid any types of undesired situations and then only the overall tourism industry would benefit. The visitors should think that the managements of the tourism organizations are capable enough to secure their safety and then only the industry would be able to bounce back and generate profitability like before. Bibliography Mikuli?, J., Milo Spr?i?, D., Holi?ek, H. and PrebeÃ… ¾ac, D. (2018).Strategic crisis management in tourism: An application of integrated risk management principles to the Croatian tourism industry. Ritchie, B.W. and Campiranon, K. eds., 2014.Tourism Crisis and Disaster Management in the Asia-Pacific(Vol. 1). CABI. Scarpino, M.R. and Gretzel, U., 2014. Conceptualizing organizational resilience in tourism crisis management.Tourism crisis and disaster management in the Asia-Pacific,1, p.15. Williams, A.M. and BalÃ… ¾, V., 2015. Tourism risk and uncertainty: Theoretical reflections.Journal of Travel Research,54(3), pp.271-287.