Given that there is no expectation of substantial equivalence, the following process will need to be undertaken. The 510(K) that needs to be submitted is the Traditional. A Special is for modifications to products that already have 510(k) approval, Continue Reading...
Translating Biomedical Innovation / Mental Health and well being Managing Ideas: Commercialization Strategies for Biotechnology This article by Joshua and Scott Focuses on the commercialization aspect of biotechnology and stresses how important it Continue Reading...
Medication Errors Since the research materials are provided to you by human beings, and may be based Medication errors pose a significant threat to patients. The results of medication errors vary from mild to deadly. No facility is immune from the Continue Reading...
..for cleansing, beautifying, promoting attractiveness, or altering the appearance" while a drug is "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "intended to affect the structure or any function of th Continue Reading...
Patient and family education is essential especially with regards to eating habits. The patients should avoid excess fat in their diet as it contributes to high chances of contracting the disease (Bolen et al. 2010). The drug has, however, remained Continue Reading...
Organic Pet Store The legal and regulatory environment for an organic pet store is relatively straightforward, with limited regulations. All of the products must be approved by the FDA, which means that all suppliers need to go through this process Continue Reading...
Each of these consultative bodies is made up of ten to fifteen doctors and scientists with widespread knowledge about infectious illnesses, immunology and vaccine research. The statistics measured by these groups are wider than that looked at by the Continue Reading...
edu). While this example just discusses one manner in which a given policy can empower a healthcare marketing strategy, social marketing is currently so engrained in our culture that its powers are truly widespread. Social marketing allows products a Continue Reading...
Discuss the criteria used to define abnormality (abnormal behavior / mood disorders) There are no established criteria to define what is abnormal. On the other hand, every individual trait can be said as abnormal on some social plane. (Oracle thin Continue Reading...
correctly identify opportunities and threats to the products of soap and laundry detergent. Specifically, three marketing environment forces will be identified that impact this type of products. These include environmental quality factors such as se Continue Reading...
CellCept drug for the treatment of kidney complications could be a boon to lupus patients (Chang, 2005). A small study showed that the drug delivered better results than standard chemotherapy, which could cause infertility and other medical problem Continue Reading...
Fiction of Race Race Race: The cultural power of the fiction of race A recent PBS documentary was titled Race: The power of an illusion. This underlines what constitutes race -- race is a fiction, created by the faulty observational perceptions of Continue Reading...
[Harvard University] it is observed that younger patients are much better than adults in post transplantation recovery and Current statistics project a more successful picture with a reduced mortality rate for bone marrow transplantation at 5%. Also Continue Reading...
The morphological properties of the virion are non-enveloped, with isometric Necleocapsids 27 nm in diameter. The symmetry is icosahedral, with the Nucleocapsids round in shape. Further, there are 12 capsomers per neucleocapsid (ICTV). Additionally, Continue Reading...
Essay Topic Examples 1. The Evolution and Impact of Class I Medical Devices on Healthcare This essay will explore the simplest class of medical devices, Class I, which includes devices with the lowest risk to patients and users. The paper will trace Continue Reading...
) between 20 and 50. Studies have shown that people with multiple sclerosis who exercise: c.) have less fatigue How many people in the United States are diagnosed with multiple sclerosis every week? A b.) about 200 ("Take the FDA Consumer") Deal Continue Reading...
Another important aspect of the medical marijuana debate that many people are not recognizing is the potential for additional revenue. States are taxing dispensaries on their sales, and adding much-needed revenue to their coffers. Another writer no Continue Reading...
Regulation of Devices There are 3 classes of medical devices. A Class I medical device is typically designed to perform simple operations and have almost zero or no risk involved in their application. These devices are required to meet regular FDA g Continue Reading...
health law and administrative law, according to Jost (2004), are law domains that are representative of the various approaches to classification. By definition, "health law encompasses law as it affects a particular industry -- the health-care indus Continue Reading...
No medical treatment exists for treating HPV infection other than prevention through education about the dangers of multiple sexual partners and unprotected sex, because HPV infection is transmitted through sexual contact with an infected individua Continue Reading...
Translational medicine is a new discipline, which covers studies on basic science, on human investigations, non-human investigations, and translational research (Mankoff et al. 2004). Basic science studies address the biological effects of medicines Continue Reading...
(Busch, Barber, Overend, Peloso, and Schachter, 2007, p. 8) Results from this study relate a moderate quality evidence that aerobic-only exercise training at recommended intensity levels produces positive effects "global well-being (SMD 0.44, 95% c Continue Reading...
Third Class Of Drugs In the United States, all pharmaceutical products: from Advil to Zoloft, are sold either as over-the-counter remedies or as prescription drugs. Over-the-counter remedies like Advil, aspirin, and Tylenol, can be purchased by any Continue Reading...
Dental Amalgam: The Risks and Alternatives Some of the most common dental restorative materials currently in use are dental amalgams, but these compounds contain approximately 50% mercury making their use controversial, particularly with young child Continue Reading...
Essay Topic Examples 1. The Evolution of Pain Management: From Ancient Remedies to Modern Painkillers: This essay would explore the history of pain management, discussing how ancient civilizations dealt with pain and tracing Continue Reading...
GENERALIZED ANXIETY DISORDERPsychobiology and Neuroscience: Generalized Anxiety DisorderIntroductionFrom the onset, it would be prudent to note that from time to time, most people feel anxious about diverse events or occurrences in life. This is norm Continue Reading...
...It can spot moderate to severe dysplasia (irregular tissue), "some of which may turn out to be malignant and you'll have a case of lung cancer," he explains. Patients with dysplasia can then be closely monitored, and if cancer appears, it can be t Continue Reading...
(16) The drug has better coverage against Gram-positive cocci and atypical pathogens, and it is able to achieve excellent penetration into respiratory fluids and tissues. One particular adverse effect of the drug is that it may result in gastrointes Continue Reading...
Food Inc. After the current outbreaks of salmonella which brought a scare to those living in the U.S., looking at the documentary Food Inc. has actually been the best thing. This film is known as the expose of the food industry. Directed by Robert K Continue Reading...
The cassette has a built-in one-liter bladder to hold urine. The patient should empty the bladder at least every six hours. An alarm will beep if he forgets to do this, or if the bladder becomes full. The device can be used during the day, at night, Continue Reading...
Obesity Why Obesity is so Difficult to Treat Determination of obesity Proper definition of obesity Obesity in perspective of the World Health Organization (WHO) Historical trends Health and Economic Costs Prevalence and Time Trends Prevalence Continue Reading...
Specifically focused on products for each phase of a persons' life, this business segment is the most mainstream in terms of promotional strategies. Skin Care, OTC and Nutritionals have successfully given JNJ a permanent marketing strategy for selli Continue Reading...
Cocoa THE CACAO TREE (THEOBROMA CACAO) WHAT IS IN THE COCOA BEAN? MAKING AND EATING CHOCOLATE State of the Art of Cocoa Is Cocoa good for you? Burden of Proof CHOCOLATE AS A FAT EFFECTS ON BLOOD LIPIDS WHAT IS OK CHOCOLATE AND HEALTH AND D Continue Reading...
Mood Disorder Mood/bipolar disorder, also called manic-depressive illness, is a disease of the brain, which leads to unusual changes in mood, levels of activity, energy, as well as the ability to conduct day-to-day activities. Symptoms of mood disor Continue Reading...
Antidepressants and School Violence A persuasive essay, arguing link school shootings Columbine Virginia Tech, mass shootings, Aurora Theater shootings, Gabriel Giffords shooting, gunman/perpetrators psychotropic medications SSRI Antidepressants, S Continue Reading...
Ethical Analysis of Merck and Vioxx How could Merck management have handled the research, development and marketing of Vioxx in a more ethically responsible fashion, if at all? On September 30, 2004, Merck & Company declared the drawback associ Continue Reading...
Plastic Surgery Teen Plastic Surgery: A Controversial Medical Practice According to the American Society of Plastic Surgeons, in 2007, more than 87,000 teenagers had cosmetic surgery; and that number has grown exponentially since. Although aestheti Continue Reading...
Although the decision does not invalidate laws in the 11 states that have approved medical marijuana, it does prevent protection from prosecution of users and doctors who prescribe the drug (Henderson). The 11 states that have legalized medical mar Continue Reading...
Detection and Reporting of Adverse Events in Clinical Trials When conducting investigative drugs testing, there are possible unwanted effects that may some into the process, some expected yet others unexpected. These unwanted effects are referred to Continue Reading...
Since 1998, medical authorities including the editor of the New England Journal of Medicine and the National Academy of Sciences have documented marijuana's unique ability to relieve both intractable pain and nausea." We're in the Money The prohib Continue Reading...
