...One of the oldest U.S. consumer protection agencies, the Food and Drug Administration (FDA) protects the public from unsafe foods, drugs, medical devices, cosmetics, and other potential hazards. As part of the department of health and human services, the FDA annually regulates over $1 trillion worth of products, which account for one-fourth of all consumer spending in the United States. It also protects the rights and safety of patients in clinical trials of new medical products, monitors the promotional activities of drug and device manufacturers, regulates the labeling of all packaged foods, and monitors the safety of the nation's blood supply. To ensure compliance with its regulations, the FDA employs over 1,000 investigators and inspectors who visit over 15,000 food-processing, drug-manufacturing, and other facilities each year. If it finds violations of law, the FDA first encourages an offending company to voluntarily correct the problem or to recall a faulty product from the market. If the firm does not voluntarily comply with the law, the FDA may take it to court and seek criminal penalties against it. The FDA may also seize faulty products, order product recalls, seek injunctive relief, impose fines, and take other types of enforcement action. Each year, the FDA declares about 3,000 products and 30,000 import shipments to be unacceptable in various ways. The FDA employs over 2,000 scientists—including 900 chemists and 300 microbiologists—who provide the scientific...
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...treatments and therapies. The use of stem cells has opened up a new field called regenerative medicine or cell therapy, which replaces damaged or diseased cells that are in the body with new ones. Stem cells have the ability to develop into many different cell types within the body during the early life and growth cycle. Stem cells repair internal system, by dividing and replenishing other cells. They distinguish themselves by being unspecialized cells, renewing themselves through cell division and under certain physiologic conditions, be chemically induced to become tissue or organ-specific cells with particular functions. There are several different types of Stem Cells: Embryonic Stem Cells (hES), which are derived from embryos, mostly from eggs fertilized in vitro and donated for research with the donor’s permission. Adult Stem Cells (hES), are undifferentiated cells found among differentiated cells in tissue and organs, which can differentiate themselves to yield some or all of the major specialized cell types of that tissue or organ. iPSC Stem Cells: Are also adult cells, genetically reprogrammed to an embryonic stem-cell like state and forced to express genes and factors to define the properties of the embryonic stem cells. Stem Cell applications can be classified into several categories, one is research: research in developmental Biology, which are models of human disease constrained by animal and cell cultures. Two is transplantation, three, is gene therapy and development...
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...declarationI certify that the work submitted for this assignment is my own. I have clearly referenced any sources used in the work. I understand that false declaration is a form of malpractice.Learner signature: Maddie johnson Date: 05/10/15 | RESUBMISSION AUTHORISATION A resubmission has been authorised as the learner: * Has met all agreed deadlines * Is judged to be able to provide improved evidence without further guidance | Assessor Name | | Assessor Signature | | Lead IV Name | | Lead IV signature | | Date agreed | | Resubmission Deadline date | | Learner Assessment RESubmission and Declaration Submission date: | Submitted on: | RESUBMISSION EVIDENCE | Task ref. | New evidence submitted | Page numbers ordescription | | | | | | | Additional comments to the Assessor: | Learner declarationI certify that the work resubmitted for this assignment is my own. I have clearly referenced any sources used in the work. I understand that false declaration is a form of malpractice.Learner signature: Date: | ‘’ Working together for Britain's national health ’’ I have chosen to research about Pfizer, which is one of the...
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...become operational without the oncology department within the next couple of months. Said Debashish Poddar, managing director, BP Poddar Hospital & Medical Research Limited, "It will not be a so called state-of-the-art hospital but a hospital, which will ensure healthcare deliver of international standards within the affordable limits of the common man. The hospital is the culmination of the dream of Arun Poddar, Chairman of the Group and his family to perpetuate the memory of his father Late BP Poddar, he added. Despite being a multispeciality unit, the focus area of the hospital will be oncology. All possible imaging facilities will be provided at the hospital. The management has applied for necessary regulatory clearances from Bhaba Atomic Research Centre (BARC) to start radiation therapy for treatment of cancer. According to Dr Subrata Das, medical director, BP Poddar Hospital & Medical Research Limited, "With a few dedicated hospitals in the region dedicated to oncology, the proposed hospital will take care of all the needs of the cancer patients. We are in the process of installing the latest equipment in the hospital to provide the best possible medical care." The management will be investing substantially on training of human resources. Said Shantanu Ray, a renowned academician and a director of BP Poddar Hospital & Medical Research Limited. To make patient feel that he is not in a hospital, the management has emphasized on adding a dash of colour to the costumes of...
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...To date, there is no proven vaccine or cure for Ebola. Without a vaccine, the virus poses a great threat to global public health. Standard treatment is still confined to supportive therapy. Supportive therapy is done in patients through administering intravenous fluids (IV) and balancing electrolytes or body salts, sustaining oxygen levels and ensuring normal blood pressure, and treating patients for consequent complicating infections. Early supportive care, coupled with proper rehydration and treatment of the symptoms will improve survival. Contracting Ebola does not categorically equate to death. With proper care, there is a good chance that patients will survive this disease. Within a few days after manifesting the symptoms, tests such...
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...Atrial Fibrillation: Part I. Rate and Rhythm Control DANA E. KING, M.D., LORI M. DICKERSON, PHARM.D., and JONATHAN L. SACK, M.D. Medical University of South Carolina, Charleston, South Carolina Atrial fibrillation is the arrhythmia most commonly encountered in family practice. Serious complications can include congestive heart failure, myocardial infarction, and thromboembolism. Initial treatment is directed at controlling the ventricular rate, most often with a calcium channel blocker, a beta blocker, or digoxin. Medical or electrical cardioversion to restore sinus rhythm is the next step in patients who remain in atrial fibrillation. Heparin should be administered to hospitalized patients undergoing medical or electrical cardioversion. Anticoagulation with warfarin should be used for three weeks before elective cardioversion and continued for four weeks after cardioversion. The recommendations provided in this two-part article are consistent with guidelines published by the American Heart Association and the Agency for Healthcare Research and Quality. (Am Fam Physician 2002;66:249-56. Copyright© 2002 American Academy of Family Physicians.) I Members of various family practice departments develop articles for “Practical Therapeutics.” This article is one in a series coordinated by the Department of Family Medicine at the Medical University of South Carolina. Guest editor of the series is William J. Hueston, M.D. This is part I of a twopart article on...
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...Multiple Sclerosis (MS): An Autoimmune Disease. You are in your mid twenty but you feel fatigue, numbness of extremities, chronic pain, vision problem, etc almost daily. Then sometime, you feel dizzy, vertigo, loss of balance, involuntary muscle spasms, and difficult to move around. You may feel depress and mood swings in addition to these symptoms. What is wrong with you? You are at the age where as young adults with full energize life ahead, ready to take charge of an independent life and assume a various social roles and economic responsibilities like a new career after college and graduate school, begin an intimate romance relationships, or maybe starting a family of your own (Falvo, 2009). What you are experiences are the common symptoms of Multiple Sclerosis (MS), a Central Nervous System (CNS) disease which affects over 400,000 Americans, and every week about 200 people are diagnosed. Worldwide, it affects about 2.5 million people (NewsRx Health and Science, 2012). Its exact cause is unknown, however the common thought is some unknown virus or gene defect is the blame. To really understand Multiple Sclerosis we will need to look at it definition and history, the statistics of number people afflicted with it, what are the social-psychological challenges of the disease. We will also need to look at what kind of research projects and experiments have been done regarding the disease, what kind of help and support that the community have to offer to its patients,...
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...grow worse as muscles progressively degenerate and weaken. Many patients eventually lose the ability to walk (“National Institute,” 2011). Some types of MD also affect the heart, gastrointestinal system, endocrine glands, spine, eyes, brain, and other organs. Respiratory and cardiac diseases may occur, and some patients may develop a swallowing disorder. MD is not contagious and cannot be brought on by injury or activity (“National Institute,” 2011). Method(s) of diagnosis Muscular dystrophies are diagnosed through both the patient’s medical history and a complete family history to determine if the muscle disease is secondary to a disease affecting other tissues or organs or is an inherited condition. It is also important to rule out any muscle weakness resulting from prior surgery, exposure to toxins, current medications that may affect the patient's functional status, and any acquired muscle diseases. Thorough clinical and neurological exams can rule out disorders of the central and/or peripheral nervous systems, identify any patterns of muscle weakness and atrophy, test reflex responses and coordination, and look for contractions. Various laboratory tests may be used to confirm the diagnosis of MD (“National Institute,” 2011). Blood and urine tests can detect defective genes and help identify specific neuromuscular disorders. For example: * The level of serum...
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...of diseases using medical and health care professionals. Jacobsen (2012) cites that health care sector offers variety of exiting careers which health professionals can pursue including; health management, medical equipment sales, research, and discovery as well as clinic and chronic care centers management. All these areas have their specific importance in ensuring quality health delivery to people who seek medical services. One of the most interesting areas of health care for me is the medical research. Health or medical research is a systematic way of evaluating human infections and learning more about human health with the aim of discovering the human health disorders and inventing strategies for the preventing and treating human diseases (Jacobsen, 2012). It also involves the evaluation of safety and effectiveness of particular treatment procedures, validation of a course of treatment and collection of data that will allow future analysis of the study. History of Health Research and the Future Although health research dates back to early 14th century, active scientific approach to health care challenges started with studies about the antibiotics after the Second World War. The discovery of penicillin and vaccines like polio and measles opened studies for several drug and disease which later led to eradication of certain communicable diseases (Jacobsen, 2012). The research has enabled development of over 1,000 drugs which are approved by Food and Drug Administration (Polgar...
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...periodically visit a doctor’s office or hospital. Compare and contrast monitoring of patient vital signs using mobile computing technology to in-patient visits to the doctor’s office or hospital. With the new information age, health care providers are expected to keep up with the new healthcare technologies, treatments, medications, and different procedures that are introduced to our consumers at a rapid pace. Traditional medical practices in the past have made this process almost impossible because the systems were unable to organize, store, and retrieve medical and patient information. But today's information systems have made the impossible possible. With new technology, come technical problems that will have both pros and cons in mobile computing technology for better and safer health care. Some problems include improving the quality of patient care and patient safety, preventing medical errors, reducing healthcare costs, helping patients manage their conditions better, and minimizing the impact of the new enemy we all face-bioterrorism. In 1968, the Massachusetts General Hospital developed the COSTAR (Computer Stored Ambulatory Record) which creates and stores an electronic version of the patient's record which includes information from their medical history, lab reports, physical examinations, diagnosis, and treatment (Kass-Bartimes & Ortiz, 2002). This high-tech...
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...IV/AIDS is one of the world's greatest leading causes of death. Today, it is one of the world's most well known diseases and most feared, because it currently has no cure, knows no race, age, or gender but if not, “Nipped in the bud” will engulf the entire world. Researchers are slowly proving that there is a cure for the HIV virus in a near future and we should support the organizations that fund the research. Human Immunodeficiency Virus (HIV) is the virus that can lead to Acquired Immunodeficiency Syndrome, or AIDS. Unlike some other viruses, the human body cannot get rid of HIV, once you contact HIV, you have it for life. HIV affects specific cells of the immune system, called CD4 cells, or T cells. Over time, HIV can destroy so many of these cells that the body can’t fight off infections and disease which then leads to AIDS. Within 2-4 weeks after HIV infection, many, but not all, people experience flu-like symptoms, often described as the “worst flu ever.” This is called “Acute Retro-viral Syndrome” (ARS) or “primary HIV infection,” and it’s the body’s natural response to the HIV infection. Symptoms can include fever (this is the most common symptom), swollen glands, sore throat, rash, fatigue, headache, muscle and joint aches and pains. These symptoms can last anywhere from a few days to several weeks. However, one should not assume that they have HIV if any of these symptoms should appear. Each of these symptoms can be caused by other illnesses. Conversely, not everyone...
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...expanding pharmaceutical market Government-provided healthcare improving, but private healthcare dominates Domestic market overview 09 Background Consolidation underway, despite challenges Contract manufacturing Vaccines Over the counter market holds significant potential Reaching the untapped rural market Growing Research & Development 15 Overview Clinical trials Biotech and biosimilars on track for growth Other growth areas Bioinformatics 20 Stem cell research Medical devices Global Pharma’s evolving business models and options in India 23 Background Export-oriented business (Contract Research and Manufacturing Services) Licensing Franchising Joint ventures Wholly-owned subsidiaries Practical concerns 27 Infrastructure Tax environment Counterfeiting Intellectual property Conclusion 30 Related reading: Pharma 2020 31 References 32 Acronyms 38 Introduction The pharmaceutical industry’s main markets are under serious pressure. North America, Europe and Japan jointly account for 82% of audited and unaudited drug sales; total sales reached US$773 billion in 2008, according to IMS Health. Annual growth in the European Union (EU) has slowed to 5.8%, and sales are increasing at an even more sluggish rate in Japan (2.1%) and North America (1.4%).1 Impending policy changes, promoting the use of generics in these key markets are expected to further dent the top- and bottom-line of...
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...Technological Environment With new innovations constantly on their way, new products are brought into the market that creates new market genres. In today’s weight loss industry, technological progression continues to open up new ways to exercise, stay in shape and promote great health. Whether it’s a new exercising method, a device to help workout and burn extra calories or a product that assists athletic necessities, companies today must seek out and provide their consumers with the latest technological improvements just to maintain the consumers’ loyalty. The companies that thrive for success in this competitive market often upgrade their products every chance they get along with promoting the product’s latest improvement. For example, the sports footwear company New Balance opened a sports research lab in its Lawrence, MA, facility. An article by Lou Dzierzak reveals: The modern 3,000-square-foot facility houses state-of-the-art biomechanics equipment, office space, a 120-foot running tract, 30 foot by 30 foot court and smash lab. The facility will focus on technology and product testing, innovation research, education and will host customer visits… This lab helps us join together that real-world athlete testing with the biomechanics. And with that better understanding, we can correlate mechanical and biomechanical measures to what athletes are really feeling. The investment in the new research lab facility provides New Balance with the latest technology to...
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...Inc. Is changing the face of chronic disease. By working closely with the physicians around the world, they create therapies to help patients do things they never thought possible. Their medical technologies help make it possible for millions of people to resume everyday activities, return to work, and live better, longer. They are able to do this with the help of some very special people around the world: 38,000 dedicated employees who share a passionate purpose to improve lives, thousands of medical professionals who share their insights and ideas, and hundreds of advocacy associations that help us share information so people with debilitating diseases know relief is possible. MEDTRONIC PURPOSE Medtronic is one of the largest medical technology companies that manufactures implantable biomedical devices, with sales in over 120 countries. The Company treats chronic diseases by offering products including bradycardia pacing, heart failure, atreal fibulation, coronary vascular disease, heart valve replacement, etc. They operate Cardiac Rhythm Disease Management, Spinal and Biologicals, CardioVascular, Neuromodulation, Diabetes, and Surgical Technologies. Medtronic, Inc. was founded in 1949 by Earl Bakken and his brother in law Palmer Hermundslie out of their garage in northeast Minneapolis, Minnesota. They turned their garage into a medical equipment repair shop. They originally wanted to sell basketball pumps since there was a shortage of them in the Midwest during...
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...Supply Chain Efficiency in the Healthcare industry Introduction Healthcare in US is a major area with the country spending almost 16% of its GNP on healthcare costs. The healthcare industry is expected to grow and consume a greater share in the next few years. Hospitals are complex organizations providing a multitude of services to patients, physicians, and staff. These services include dietary, linen, housekeeping, physical plant engineering, pharmacy, laboratory, inpatient treatment (nursing units), surgery, radiology, administration, and others. In the national debate over how to make U.S. healthcare more efficient, one promising area for reform is often overlooked: supplies. Whether the products are knee implants, pacemakers, or expensive medications, hospitals have long purchased whatever doctors desired with little discussion among the parties involved about cost. Healthcare supply chain system is an extremely complex “adsorption model” that moves products downstream with limited visibility into product demand at the point of use. The outcome of the current model results in products that can be out-of-stock as much as 15 percent of the time. The pressures on hospital supply chains are changing too. In the past, a hospital that managed its purchasing costs well could operate efficiently. Today, the cost of materials management can exceed 35% of a hospital's operating budget, with nearly 20-25% attributable to supply costs alone. Despite the supply chain representing...
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