Fda Essays


Child Psychology

place naturally. Psychology Press Ltd. Observational Research. (2005, May 27). Retrieved from fda: http://www.fda.gov/ohrms/dockets/dockets/05p0224/05p-0224-cp00001-Exhibit-18-Observational-Research-vol1.pdf Continue Reading...

Role Of the Fda with Prescription Drugs

pad the prescriptions that are being filled. However, that is a regulatory issue for the fda if it comes to that and not all doctors give into that pressure. Indeed, many doctors aim to give the best advice and the best drugs based on the situations and health issues as they exist rather than what is most profitable for the drug companies or the doctor's office or location in question (Das, 2012). As for what the fda could have or should have done, it is interesting and a bit concerning that Compcare, at Pharmacare's direction, would be able to… Continue Reading...

Legal Psychology and Victimization

The impact of the psychological profiles of the offender and victims on the court evidence presented by the prosecutor and defense teams and witness use Psychological profiling involves developing a composition of behavioral attributes. It combines psychological and sociological review of the offender. The process of profiling is anchored on the premise that if the crime scene is analyzed carefully and accurately, there is a good chance that the type of person involved in the offence will begin to surface. Therefore, it is based on the idea that some types of people manifest certain behavior tendencies and patterns. A jury… Continue Reading...

Meaning Of a Biblical Passage

Scripture The process of studying Scripture usually requires and involves more than reading surface text because an individual has to conduct an in-depth study. An in-depth study of text is a necessary process towards understanding the meaning of a passage from Scripture and grasping it fully. In essence, for an individual to gain a rich understanding of the meaning of a passage from a Scripture from different perspectives, it is important to conduct an in-depth study rather than just surface reading of the text. One of the most important aspects of gaining understanding of the meaning of a text is… Continue Reading...

Consumer Protection Memo

legislations and enforced by various organizations such as the Food and Drug Administration ( fda) and the Consumer Product Safety Commission (CPSC). Adhering to these regulations is important for not only ensuring consumer health and safety, but also avoiding expensive litigation as well as loss of customers, revenue, and public confidence. References Argo, J., & Main, K. (2004). Meta-analyses of the effectiveness of warning labels. Journal of Public Policy & Marketing, 23(2), 193-208. Purmehdi, M., Legoux, R., Carrillat, F., & Senecal, S. (2016). The effectiveness of warning labels for consumers: a meta-analytic investigation into their underlying process and contingencies. Journal… Continue Reading...

Business News from Around the World

a drug for market consists of testing and reporting to the fda, this pledge by the White House is one that could enable drug manufacturers to feel inclined to lowering prices, as their overhead would also dwindle should regulation become less stringent. However, a deregulated pharmaceutical industry could spell danger for consumers, especially if the easing of rules leads to fewer products that are proven to be safe and effective hitting the market. Nonetheless, Trump's populist message is here seen being coupled with his pro-business platform: thus, one the one hand he is appealing to "public outrage over the… Continue Reading...

Herbal Medication in Handling Heart Diseases Among Women

widely informed by the ever rising use and need to use the herbal medicine in the USA. The fda has weighed in especially in terms of the safety concerns of these various herbs hence this article objectively looks at the issues concerning the benefits, the adverse effects and the therapeutic value of various herbal therapies particularly among patients with cardiovascular diseases. The article highlights the challenges that the herbal medicine faces in terms of the regulations and standards setting is concerned. Many manufacturers are seen not to bother about the labeling and indication of chemical content of the herbs… Continue Reading...

Adverse Effects Associated with Hyland Teething Tablets

associated with Hyland's teething tablets? According to investigations conducted by the U.S. Food and Drug Administration ( fda) regarding the Hyland's teething tablets in 2010, it was established that the drug does contain belladonna. Belladonna is a substance known to cause serious harm when consumed in huge doses. The fda recognized whenever such a product was being used there should be careful controls in place to ensure that the amount being used is properly measured and controlled. According to the fda laboratory results, it was established that Hyland's teething tablets contained inconsistent amounts of belladonna (Food and Drug Administration, 2016). This… Continue Reading...

Cloud Service and Prescription

diagram means including healthcare policy, prescription drugs regulations, and technology. For example, the fda and HIPAA regulate prescription drugs (fda) and set the standards for security of health information systems (HIPAA). Legal services check the terms and guidelines of contracts. This represents the GUIDES side of the INPUTS and OUTPUTS prescription process. The INPUTS side has cloud service costs, prescription and patient data, and updated software/maintenance costs. This is what goes into sending a prescription, receiving a prescription, and performing the necessary tasks to get the prescription to the patient. The OUTPUTS involve a cloud service license, support and… Continue Reading...

Use Of Chlorhexidine to Prevent Healthcare Associated Infections

In the U.S healthcare environment, the clinical practice guidelines are the effective healthcare protocol to enhance patient’s safety as well as achieving evidence-based practice. The clinical guidelines provide recommendations to the best available practice to assist clinicians and other healthcare professionals to deliver best and quality care. More importantly, the clinical practice guidelines are designed to optimize patients’ care using the systematic assessment and evidence based review to assess pros and cons of the alternative care options. The guidelines serve as the strongest resources to assist the healthcare professionals to make clinical decisions as well as incorporating evidence gained through… Continue Reading...

Ethical and Legal Considerations Intellectual Property and Product Safety

are of pharmaceutical nature. Issues to do with wrongful administration and quality suffice. fda is under pressure t cope with the emerging challenges in its regulation of direct to consumer approaches because drug units could easily be transformed into the purely commercial outfits with little consideration for consumer safety and wellbeing. Therefore, although there are arguments that DTC helps to avail drugs to the consumer easily and fast, there are heavy risks that may lead to paying very heavy prices. A case in perspective is PharmaCARE; the company provided misleading information about AD23 to the consumers. The drug had… Continue Reading...

Social, Legal, and Ethical Issues in Marketing

a comparatively new one. References Cohen, M. H. (2015). Energy drinks raise a monster of fda and state legal concerns. Retrieved from: http://www.michaelhcohen.com/2015/01/energy-drinks-raise-monster-fda-state-legal-concerns/ Law Info. (2017). Energy Drink Lawsuit. Retrieved from: http://lawsuits.lawinfo.com/EnergyDrinks/index.html Mintz, S. (2013). Is Monster Drink Legally or Ethically Responsible for the Death of Young People? Ethics Sage. Retrieved from: http://www.ethicssage.com/2013/07/is-monster-drink-legally-or-ethically-responsible-for-the-death-of-young-people.html Richards, G., & Smith, A. P. (2016). A review of energy drinks and mental health, with a focus on stress, anxiety, and depression. Journal of caffeine research, 6(2), 49-63. Continue Reading...

Robotic Surgery Essay

this was the first robotic surgery device that was granted approval by the fda (Lanfranco, 2004). The ROBODOC had to go through the standard fda approval system for medical devices. The process was instituted in the 1970s, therefore in an era where there were no robotic medical devices.  A robotic surgical device would be a Class III device, the highest risk category, and therefore would have the highest level of regulatory burden.  The ROBODOC's approval took  much longer than it could have because the patent owners would go bankrupt before the approval process could be completed.  As a result,… Continue Reading...

Practice Of Dumping Essay

cannot play nanny to the rest of the world” (p. 223). Likewise, the fda commissioner at the time, Frank Young, claimed that, “Each sovereign government has the chief responsibility to determine the types of drugs that can be imported from abroad [and] it was arrogant for the United States to attempt to dictate drug policy to any developing nation” (cited in Silverman & Lydecker, 1999, p. 224). There are also some more pragmatic reasons for dumping that can be considered as having a benefit for countries that import these products. Because the U.S. has set exceedingly high safety standards… Continue Reading...

Difference Between Steroids and Hgh

as they have not been reviewed and approved by the Food and Drug Administration ( fda), in addition to being blatantly illegal to develop or use (Mayo, 2017). The tried and true lessons of exercise science also show that there are other problems that can occur with steroid use. The aforementioned diuretics, which are relatively harmless when used in the right way, can themselves cause their own health issues. These negative outcomes and effects include dehydration, drop in blood pressure, dizziness, muscle cramps, potassium deficiency, gout, loss of balance and/or coordination or even death. Even creatine, which is commonly not… Continue Reading...

Coca Cola Analysis

impacting the company: trade restrictions, tax policy, labor laws, environment policy, fda certification, etc.; Economic factors: gross domestic product, interest rates, forex rates, disposable income, retail price index, demand and supply conditions, and unemployment rates; Social factors: trends, practices, traditions, wants, population, educational qualifications, aspirations, income distribution, corruption, customer awareness and education, standard of living, religious values, and family structure; and technological factors. Introduction Key Facts Name: The Coca-Cola Company Industries served: Beverage (more than 600 brands) Geographic areas served: Worldwide (more than 200 countries) Headquarters: Atlanta, Georgia, United States Current CEO: James Quincey Revenue (US$): 41.863 billion (2016)… Continue Reading...

Clipboard Tablet Co Marketing and R&d Analysis

follows: Political and Legal Factors potentially impacting the company: trade restrictions, tax policy, labor laws, environment policy, fda certification, etc.; Economic factors: gross domestic product, interest rates, forex rates, disposable income, retail price index, demand and supply conditions, and unemployment rates; Social factors: trends, practices, traditions, wants, population, educational qualifications, aspirations, income distribution, corruption, customer awareness and education, standard of living, religious values, and family structure; and technological factors. Introduction Key Facts Name: The Coca-Cola Company Industries served: Beverage (more than 600 brands) Geographic areas served: Worldwide (more than 200 countries) Headquarters: Atlanta, Georgia, United States Current CEO: James… Continue Reading...

21st Century Cures Act

to reach the intended beneficiaries (the patients) faster. The law derives inspiration from work by fda to include the views of patients into drug development, biological devices and products in the process of making decisions by the fda. The ability to modernize clinical trial plans and outcome assessments; which will hasten the review of novel products in the medical field, and creation of medical counter-measures have been made possible by the Cures Act (fda, 2017). The Act provides new authority that will assist fda to bolster our recruitment and retention of scientific, professional and technical experts. It also initiates… Continue Reading...

Indwelling Urinary Catheter Care

Research Proposal for Catheter Associated Urinary Tract Infections Catheter Associated Urinary Tract Infections (CAUTI) affects timely reimbursement and prolongs patient stays in the healthcare facility. Many hospitals strive for ways to reduce CAUTIs and take specific medical measures to aid patients in recovery from the same and avoid recurrence of the cases of CAUTIs. These deliberate measures ensure so they can have better patient outcomes and improve patient care. This also improves the reimbursement received from insurance providers. Research question The research seeks to investigate the effect of frequent CAUTI education, among the in-hospital patients with indwelling urinary catheter, conducted… Continue Reading...

Women Empowerment in Iran

In order to understand the position of women in Iran as far as their roles, rights and empowerment is concerned, it is significant to understand the wider picture of the prevailing condition in the Middle East and the contrast that there is in the West. These two represent different polarities in the context of culture, perspective on women, roles assigned, rights granted and the positions that women hold in these two societies. There is a still not an in depth understanding of the lives of women in the Middle East and the roles that they are meant to play. In… Continue Reading...

E Cigarettes Ethical and Cultural Issues

e-Cigs. The present regulations outlaw selling tobacco products to minors. The Center for Tobacco Products of the fda has the power to control cigarettes. According to the fda, e-Cigs are cigarettes. The fda already started crafting regulations to govern the e-cigarettes sector. Nevertheless, since the law is not yet in place, it appears that the sale of eCigs even to minors remains legal. However, given the trends, one should be able to tell that in time there will be some kind of restriction at federal government level regarding the use of eCigs. The law making process includes a public… Continue Reading...

Assessing the Benefits Of Marijuana

to the very same thorough scientific examination and clinical trials applied by the fda (Food and Drug Administration) to every other novel medication. This inclusive process aims at ensuring highest efficiency and safety standards (FOCUS). The American government’s marijuana ban had the unintentional effect of ensuring considerable quantities of cannabis were secretly grown indoors, where they could be cultivated under controlled conditions. Further, growers could steadily increase THC levels, which is the psychoactive ingredient in the plant. Owing to indoor growers' fervent attention to all needs of the plant, the author Pollan considers these illegal cannabis growers "the best… Continue Reading...

Economic Analysis Of Supply and Market Structure Of Healthcare Industry

to do so is tantamount to turning one’s back on the American people. The fda has even recently admitted that it needs to do something regarding prices (Laff, 2017). References Dabora, M. C., Turaga, N., & Schulman, K. A. (2017, July 4). Financing and Distribution of Pharmaceuticals in the United States. Retrieved from https://jamanetwork.com/journals/jama/fullarticle/2627994 Laff, M. (2017, August 2). Regulation, Competition Needed to Lower Drug Prices, Says Panel. Retrieved from https://www.aafp.org/news/practice-professional-issues/20170802prescriptioncosts.html VanEck, V. (2016, March 9). Market Realist. Retrieved from https://marketrealist.com/2016/03/what-are-generic-drugs-and-why-are-they-important Wapner, J. (2017, March). How prescription drugs get their prices, explained. Retrieved from http://www.newsweek.com/prescription-drug-pricing-569444 Continue Reading...

False Advertising

be held liable for what the firm does, especially after being warned by the fda that he and his firm are not in compliance with safety precautions and guidelines put forward by the fda. Those rules are put out there to protect the public because the public will be consuming the food items being warehoused by Mr. Park’s company—and there is a rodent problem there. So the fda comes in to protect the public and tell Mr. Park to fix the problem. If the problem is truly unfixable then the fda is wrong to prosecute Mr. Park—but though pest… Continue Reading...

American Families and Health

United States have traces of weed killer in it as investigated by the fda. Weed killer is a harmful pesticide that adversely affects the health of people. Yet, somehow it permeates many foods Americans consume. Even if people try to live healthy, they cannot and end up depressed or feel anxious. This is the world that people live in and it seems problematic. People need to champion for their rights and their health. Health is the most important thing, and, in the future, I do not see many people being healthy. I see people feeling miserable, experiencing chronic health… Continue Reading...

Unhealthy Behavior Drinking Inadequate Water

water supplies should be tested for pollutants several times a day. In the contrary, the Food and Drug Administration ( fda) stipulates that private bottlers should test water for pollutants either weekly, yearly, or once in four years. (McLennan, 2000) Many people have become extra busy of late, to the point of forgetting something as easy as drinking water. This may take a toll on them without realizing, since they are pre-occupied with other things. Outlined below are a variety of strategies one can apply to ensure they drink enough water every day. (Simpson, & Mazzeo 2017) Drink water in… Continue Reading...

Salmonella Infection

foods come in contact with juice from raw poultry and meat. Additionally, the fda (Food & Drug Administration) has attributed a few salmonella outbreaks to contaminants within spices and has been looking for a means of increasing spices’ safety (Nordqvist, 2017). The Environment Weather pattern alterations may result in microbial contaminant transfer to herbs and leafy vegetables. Dry spells might give rise to dust storms, when dust settles on these green vegetables. Microbial growth rate increases with increase in temperature, impacting the populations of pests and insects situated around and in farms and causing human pathogen transfer to these vegetables.… Continue Reading...

Programs for Risk Management for Health Care Organizations

and application of advanced IT in healthcare and exchange of health information (TechTarget, 2018b). fda (Food and Drug Administration) regulates medical devices and equipment effectiveness and safety. It entails the approval of medical devices prior to them getting into the market and defining the standards for manufacture and performance as well as tracking any malfunctions on devices and any detrimental adverse reactions (TechTarget, 2018b). Incident Risk Management Plan compliance with the American Society of Healthcare Risk Management (ASHRM) standards relevant to privacy, health care worker safety, and patient safety. ASHRM was established for the promotion of innovative and effective strategies… Continue Reading...

Pay for Performance

health care sector through the Food and Drug Administration ( fda). The new fda commissioner has put into effect some policies to to address issues such as increasing drug review efficiency, high prices for drugs, pursue digital health technology, innovate medical devices, and clearing the orphan drug request backlog. What does the future hold for pay-for-performance? Federal Government agencies have lately devised better systems of pay-for-performance by emphasizing on performance and not tenure. It is evident that any agency wishing to implement a successful pay-for-performance system must invest money, time and effort in the conception and implementation stage. (Barello et.al… Continue Reading...

Company Strategy Merck Versus Pfizer

be sold in the form of a much cheaper generic. The fda shortened the patient life of drugs from 11-12 years from 17-20, thus vastly reducing the financial ability of companies to cash in on valuable non-generics (Collis & Smith, 2007, p.5). The industry structure also changed significantly, as more and more companies began to enter into the fray of developing new drugs. With the expansion of the European Union, approval was facilitated for new drugs across all member nations, thus empowering European companies with the ability to make greater profits (Collis & Smith, 2007, p.6). The developing nations… Continue Reading...

Clostridium Botulinum

Bad Bug Book of the U.S. Food and Drug Administration ( fda) the common bacterium Clostridium botulinum is an “anaerobic, Gram-positive, spore-forming rod that produces a potent neurotoxin (108). Most individuals are probably best familiar with the spore as botulism. Botulism is a foodborne illness that has grown mercifully less common with the rise of canning and appropriate food sanitization measures, although it is still present in many countries and it still claims lives. The Bad Bug Book states that botulism’s early symptoms vary, depending on the particular case, but usually manifests within 18-36 hours (The Bad Bug Book, 108).… Continue Reading...

An Argument in Support Of Vaccination

According to the U.S. Food and Drug Administration - fda, given that the vast majority of vaccines manufactured every year are meant to be administered to adults, children, as well as babies who are of good health, the safety of such doses ought to be paramount. One of the ingredients of some vaccines in use today, and that has been frequently cited as being a harmful, is aluminum. According to Offit and Moser (63), neurological harm could afflict those who ingest excess aluminum. fda downplays these fears. In essence, according to fda, “aluminum adjuvant containing vaccines have a demonstrated… Continue Reading...

The Cbd Oil Craze

and could even be taking products containing THC in them (Thompson, 2018). The fda has specifically approved only the pharmaceutical brand of CBD-containing medication Epidiolex. In fact, the only medical condition for which Epidiolex can be legally prescribed throughout the United States is for Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS). Both LGS and DS are forms of childhood epilepsy (Johnson, 2018). Other than for these rare conditions, the fda has not yet approved CBD at all and the supplement remains technically illegal except in states with legal medical or recreational marijuana. However, CBD is typically derived from hemp and… Continue Reading...

Economic Disadvantages and Respiratory Issues

previously active ingredients contained in non-prescription asthma drugs. Both of them are now, however, categorized prescription-only drugs. The fda has taken several actions concerning the control of non-prescription drugs for asthma over the last thirty years. Back in 1976, it established that inhaled epinephrine offered effective and fast relief in moderate to mild asthma patients. In 1982, the fda again concluded a provisional final monograph: epinephrine hydrochrolide, epinephrine bitartrate and epinephrine in a pressurized metered-dose inhalation aerosol dosage forms could be generally identified as effective and safe for OTC usage at a certain dose for grownups and kids of… Continue Reading...

Fire Administration and Efficient Performances

The Needs for Improved Technologies in the Operations of the United States Fire Administration for More Efficient Performances February 25, 2019 Federal Emergency Management Agency (FEMA), is a division under the United States Department of Homeland Security (DHS). Created on the 1st April 1979 by the US former president, Jimmy Carter and was brought under DHS in 2003. For almost four decades of its creation, FEMA has been relentlessly committed to helping people before, during, and after disasters, which are its obligations as stated in its statutory mission statement. The agency has been helping US residents to prevent and avert… Continue Reading...