Fda Essays Examples

Filter results by:

 

View Full Essay

Understanding Drugs

Words: 632 Length: 2 Pages Document Type: Essay Paper #: 70171420

FDA Drug Approval Process

In order for a pharmaceutical company to obtain FDA approval for a new drug, a long sequence of detailed testing and clinical trials must be administered. The approximate cost of putting a new drug through the approval is $500 million, and it takes an average of fifteen years for a drug to make it from initial testing to being available for patients. Furthermore, of every 5000 compounds that go through pre-clinical testing, only five advance to the human testing phase, and only one of these compounds will actually be approved. There are six key phases of testing that potential drugs go through on the path to FDA approval. These phases are early research / pre-clinical testing, clinical trials (phase I, phase II and phase III), FDA approval, and post-marketing testing.

The first phase of the drug approval process is pre-clinical testing. This consists of laboratory and animal testing to demonstrate biological activity of the new drug against the targeted disease. The safety of the new drug is also assessed in the pre-clinical phase. This initial phase generally takes about 6.5 years to complete

After completion of the pre-clinical phase, the drug company files an Investigational New…… [Read More]

View Full Essay

Dietary Supplements

Words: 701 Length: 2 Pages Document Type: Essay Paper #: 53766866

FDA Regulations

The FDA is responsible for the regulation of both dietary supplements and dietary ingredients. They are not regulated as food products, but are governed by the Dietary Supplement Health and Education Act of 1994 (DSHEA). The companies that market these products are responsible for ensuring that they are correctly branded and that they are unadulterated. However, the FDA does not regulate them as drugs (FDA, 2014).

I believe that this approach is adequate. I do not believe that supplements should be regulated in the same way that drugs are. There are several reasons for this. The major reason is the cost-benefit. The FDA exists to protect the public. The cost of the new drug approval process is tremendous -- it can take years and millions to bring a new drug to market, and the costs to the FDA are not inconsequential. With pharmaceuticals, this is a necessary process because they are more complex, and often have a very strong impact on the body. This is not typically the case with supplements. As the risk to humans for supplements is not much different than the risk posed by food, the regulatory cost should also not differ much.

A second…… [Read More]

View Full Essay

Robins and Robins

Words: 1013 Length: 3 Pages Document Type: Essay Paper #: 2042389

Robins & Robins

THE RIGHT THING TO DO

Robbins & Robbins

Possible Defenses by Casings, Inc.

It was the primary responsibility of Robbins & Robbins to have foreknown the risk of explosives getting into its medication before it entered into any formal agreement with Casings, Inc. Although both companies share the ethical responsibility, Robbins & Robbins should have had the greater interest in avoiding the risk. Second, the accounting firm, which worded the clause, was selected by Robbins & Robbins and was necessarily partial towards the company. And the clause was written in small 9-point font and on page 285, signifying the minimal significance given by the framer of the contract and agreed to by Robbins & Robbins. And lastly, Robbins & Robbins had known about the contamination two months before making the recall.

Blanchard and Peale Analysis

Their first of three ethics checks to determine whether a decision is right or not is its legality, either by law or company policy (Lankard, 1991). The company's recall of contaminated products came only after the knowledge of the discovery. The recall was more to save on costs than to do the right thing. It could have been aware of the contamination…… [Read More]

Bibliography:
on February 25, 2014 from http://www.ehow.com/about_4675774_waht-sovereign-immunity.html

NYPPL (2010). New York public personnel law. The Discipline Book: Public

Employment Law Press. Retrieved on February 25, 2014 from http://www.publicpersonnellaw.blogspot.com/2010/03/new-york-administrative-procedures-act.htm;
View Full Essay

PDUFA - New Drug User Fees

Words: 714 Length: 2 Pages Document Type: Essay Paper #: 38013007

Future Regulatory Improvements (FDA)

The Prescription Drug User Fee Act allows the FDA to collect fees from drug manufacturers to fund the new drug approval process. The new drug approval process is costly for both drug companies and for the FDA. The latter is funded primarily through the federal government, so this law allowed the FDA to be more self-funded. Theoretically, this would also allow it to charge fees that reflected the costs associated with conducting new drug approvals. The legislation also contained a provision that requires the FDA to conduct its approvals at a certain speed. Essentially, the bill came about because there was the risk that the FDA was going to be very slow in approving new drugs, because it was short on money. The FDA in particular was concerned at the pace Congress was providing it with more funding, during the Reagan years. This was resulting in significant cost to the industry, and this bill was seen as a compromise, allowing drug companies to basically pay for the service that they wanted. The fees would be lower than the cost of delays.

The PDUFA was intended to speed up the process of new drug approvals. Industry knew…… [Read More]

View Full Essay

Direct to Consumer Advertising History of Drug

Words: 16271 Length: 59 Pages Document Type: Essay Paper #: 71118969

Direct to Consumer Advertising

HISTORY OF DRUG ADVERTISING

THE DTC ADVERTISING PHENOMENON

CREATING DEMAND

DECEPTIVE ADVERTISING - A WOLF IN SHEEP'S CLOTHING

CAUSE OF DEATH

PROFIT

UTILIZATION, PRICING, AND DEMOGRAPHICS

LEGISLATION, POLITICS AND PATENTS

LEGISLATIVE INITIATIVES REGARDING DTC

RECALLED and/or DEADLY DRUGS

In order to provide the most efficient method of evaluation, the study will utilize existing stores of qualitative and quantitative data from reliable sources, such as U.S. Government statistical references, University studies, and the studies and publications of non-profit and consumer oriented organizations. Every attempt will be made to avoid sources of information sponsored by or directly influenced by the pharmaceutical industry.

Existing data regarding the history, levels, content and growth of direct-to-consumer advertising will be examined. In addition, the industry's composition prior to and after the proliferation of direct-to-consumer advertising will be examined, with regard to market share, type of substances sold, benefits of substances sold, and consumer benefit (or lack thereof). Perceptions regarding direct-to-consumer advertising will be revealed, from the points-of-view of the consumer, the government, the industry, and outside observers. Arising from the data gathered, a conclusion will be drawn which reflects the pros and cons of direct-to-consumer advertising and the resultant issues.

HISTORY OF…… [Read More]

View Full Essay

Food Safety

Words: 2234 Length: 6 Pages Document Type: Essay Paper #: 56924184

Food Safety Manual

Food Safety

Purpose and Scope of Manual

Foundations for Use

Safe Food Handling

The Flow of Food

Purchasing and Receiving

Storage

Preparation

Service

Hazard Analysis Critical Control Point (HACCP)

Employee Food Safety Training

Food Safety Manual

Nearly 1 in 6 Americans will become sick due to foodborne illness each year and of these, 3,000 will die (CDC, 2011). Since 1997 the number of Escherichia coli has been cut in half, but the prevalence of Salmonella infections has remained stable. Salmonella infections are estimated to be responsible for $365 million in direct medical care costs each year, thus foodborne illness continues to represent a significant medical and economic burden in the U.S. Government agencies therefore continue to investigate and promote greater compliance with food safety practices.

Purpose and Scope of Manual

The apparent success in reducing E. coli infections due to food contamination is proof that foodborne illness is a preventable condition (CDC, 2011). Towards the goal of further reducing food contamination and illness, this manual on food safety will present what is known about the causes of foodborne illness and how it can be prevented (FDA, 2009a).

Food service workers play an essential role in food safety…… [Read More]

Bibliography:
CDC (U.S. Centers for Disease Control and Prevention). (2000). Appendix B: Guidelines for confirmation of foodborne-disease outbreaks. Morbidity and Mortality Weekly Report, 49(SS01), 54-62. Retrieved 1 Mar. 2013 from http://www.cdc.gov/mmwr/preview / mmwrhtml/ss4901a3.htm.

CDC (U.S. Centers for Disease Control and Prevention). (2011, June). Making food safer to eat: Reducing contamination from the farm to the table. CDC Vital Signs, U.S. Centers for Disease Control and Prevention. Retrieved 1 Mar. 2013 from  http://www.cdc.gov/VitalSigns/AboutVitalSigns.html .
View Full Essay

Food and Drug Law in

Words: 1160 Length: 4 Pages Document Type: Essay Paper #: 77408681

S. Food and Drug Administration, because they were in wide use before the 1938 Act (grandfathered in, as it were). (Dunn 1938)

The problem was that Act contained a definition for a "new drug" (one in need of prior approval to market), as any drug "the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling." FDCA § 201(p) (1). The manufacturers set out to establish then, that anything GRAS/GRAE therefore was not a new drug, and needed no FDA blessing.

Many medicines are ancient, and the active ingredients of many drugs on were first introduced before 1938. To make matters worse, between 1938 and 1962, the FDA considered drugs that were identical, related, or similar (IRS) to any approved drug to be covered by that approval, permitting IRS drugs to be marketed without independent approval.

Naturally, some companies brought drugs onto the market between 1938 and 1962 based on their own conclusion that the products were generally recognized as safe and effective (GRAS/GRAE), or based…… [Read More]

View Full Essay

Syringe in My Pepsi Can

Words: 2051 Length: 5 Pages Document Type: Essay Paper #: 51386054

Yet, the benefits of the technique above could have turned into disadvantages if the spokesperson lost his temper, didn't know what to answer or provided details that shouldn't have reached the media.

Fourthly, the corporation established non-stop toll-free numbers. These offered two major benefits: the softening of the corporate image (PepsiCo appeared as an entity open to dialogue and concerned about the safety of its consumers) and the permanent feedback provided by consumers. Yet, the main drawback is that some joking callers could use a false identity and report untrue events just to put the company on the wrong track and make it lose time. However, benefits are heavier than drawbacks, in this case.

Fifthly, the corporation used a slogan at the end of the crisis - "Pepsi is pleased to announce...nothing." This was a witty remark suggesting that the company remained the producer of the same qualitative beverage and that the crisis created by outside sources was over.

In addition to all these, the PR department could have placed some posters in retail stores during the crisis for recommending people to pour the liquid into a recipient before drinking it (this tool has been already discussed within the framework…… [Read More]

References:
1. Gordon, K.T. (2001). Under Fire - How a Small Business Can Handle a PR Problem. On the Internet at http://findarticles.com/p/articles/mi_m0DTI/is_4_29/ai_73121444.Retrieved July 6, 2007.

2. Richardson, K. (2006). Public Relations in a Crisis: How to Make the Web Work for You. On the Internet at: www.sideroad.com/Public_Relations/public_relations_crisis.html. Retrieved July 6.
View Full Essay

Sugar Substitutes Sweet but Deadly Health Concerns

Words: 4359 Length: 15 Pages Document Type: Essay Paper #: 62558376

Sugar Substitutes

SWEET BUT DEADLY?

Health Concerns and Risks of Using Sugar Substitutes

Sweets and sugar-sweetened pop or soft drinks have recently been blamed for an increasing number of negative health conditions, such as overweight and diabetes. This has led solid soft drink consumers to turn to artificially sweetened soft drinks as substitutes. The safety of artificial sweeteners or sugar substitutes has been questioned but the impact of high intakes of artificial sweeteners on pregnant women has hardly been addressed.

The association between intakes of sugar-sweetened and artificially sweetened soft drinks and preterm delivery will be investigated.

Prospective cohort analyses of 20,000 women from the Buenos Aires national birth cohort (2012-2014) will be conducted. Their soft drink intake for more than 10 years will be assessed in mid-pregnancy through the use of a food-frequency questionnaire. The primary outcome measure will be preterm delivery at less than 37 weeks. Other information will be assessed through telephone interviews.

Conceptual Framework - The study will stress the importance of gaining knowledge about what foods are right to eat, especially during pregnancy and right after delivery, for both mothers and their offspring.

Expected Results -- will suggest a possible connection of the excessive intake…… [Read More]

Sources:
for Biomedical Communication. Retrieved on September 29, 2012 from http://www.ghr.nol.nih.gov/condition/tetrahydrobiopterin-deficiency

- (2012). Phenylketonuria. Retrieved on September 29, 2012 from http://www.ghr.nlm.nih.gov/condition-phenylketonuria
View Full Essay

Medical Devices

Words: 1016 Length: 4 Pages Document Type: Essay Paper #: 54098253

MedSun

Patton-Fuller Community Hospital

The need for reporting on adverse events related to medical device usage has never before been more salient. Medical technology has certainly been responsible for improving the quality of care, the quality of life, as well as health outcomes. However, at the same time, medical devices are being developed and released at a much faster rate than ever before. To monitor the progress and the safety of these devices, it requires a centralized monitoring system to evaluate outcomes; especially the adverse outcomes. This can allow the monitoring of devices that have issues associated with them in an efficient and effective manner and would give regulators a better opportunity to stop the usage of devices with questionable track records.

The Medical Product Safety Network (MedSun) is an adverse event reporting program launched in 2002 by the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH); the primary goal for MedSun is to work collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices (FDA, N.d.). This paper will provide an analysis of why this is an important step in improving the quality of care that hospitals can…… [Read More]

Works Cited:
Engleman, D., Rish, S., Powell, T., & Flack, M. (2008). Medical Product Safety Network (MedSun) Collaborates with Medical Product Users to Create Specialty Subnetworks . Agency for Healthcare Research and Quality, Volume I.

FDA. (N.d.). MedSun: Medical Product Safety Network. Retrieved from U.S. Food and Drug Administration:  http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/default.htm 
View Full Essay

Therac-25 Relevant Stakeholders the Patients

Words: 1587 Length: 5 Pages Document Type: Essay Paper #: 30336947

Thus, if any of us was one of the "actors', we would be tempted to judge each alternative in a subjective manner. If we were the patients, the AECL board or the hospitals we would want Therac-25 to be approved. If we were the public or FDA we would want the equipment out of the market.

The main alternative to the reality would have been for AECL to take under consideration a software error. One other alternative would have been for the company to assign more accurate probabilities for hazard occurrence, while running the Fault Tree Analysis. Finally, the third alternative would have been to use a better method to determine hazard occurrence. A better method is a method that would have been capable to return higher risks associated with the use of Therac-25 and which would have determined AECL to adjust the equipment. The first alternative is superior to the other 2 suggested as it is more logical and the probability of its occurrence is higher and if doesn't require supplementary resources as the other ones.

Reference List

Bentham J. (1996) "The Principles of morals and legislation," Oxford, England: Clarendon Press.

Griffin J. (1986), "Well Being," New York: Oxford…… [Read More]

Resources:
Roberts, M.J. & M.R.Reich (2002), "Ethical analysis in public health," the Lancet, Vol. 359: pp. 1055-1059.

Wenz P.S. CBA (1986), "Utilitarianism and reliance upon intuitions," in: Agich G.J. & Beyley C.E. eds. (1986), "The Price of Health," Boston, MA: D. Reichel.

SOCIAL and ORGANIZATIONAL RELATIONSHIPS
View Full Essay

Pharmaceutical Industry the Purpose of

Words: 2330 Length: 9 Pages Document Type: Essay Paper #: 4483356

This relationship has an effect on the payment rates that CMS sets. Higher cost pharmaceutical therapies are systematically reimbursed below acquisition cost (i.e., the payment system is biased against full reimbursement for higher cost therapies). Reimbursement compared to acquisition cost for the top IO pharmaceuticals by total expenditures indicates that 9 of the 10 are significantly under reimbursed."

Clinical Trials Report:

Congress established Medicare beneficiaries numbering 40 million with a prescription drug coverage, which has been called a "vast expansion of federal support for and control of expenditures on medicines. Even in its early stages, this program is focusing public attention on prescription drug prices, marketing, utilization, and effectiveness." (Weschler, 2004) Further stated in the Clinical Trials report is that, " the Medicare drug benefit is expected to boost prescription drug use by seniors and provide incentives to develop therapies needed by elderly patients such as arthritis, cardiovascular conditions, and Alzheimer's disease. But it also may squeeze prices and profit margins of pharmaceutical companies that sponsor research. A new payment system for oncology treatments and other therapies administered by physicians may alter incentives for R&D in these areas, while the Medicare outpatient pharmacy benefit will establish model formularies, post negotiated…… [Read More]

Bibliography:
Krupin, Stephen (2001) Study: Drug Costs Outpace Inflation. The Palm Beach Post; 6/13/2001; Washington Bureau

Congress approves Medicare drug benefit. (the Year in Review November '03) Chain Drug Review; 4/26/2004 Washington, 2004 Racher Press, Inc.
View Full Essay

Ethical and Legal Issues Related to Product Safety Marketing and Intellectual Property

Words: 1676 Length: 5 Pages Document Type: Essay Paper #: 34100951

Marketing, Product Safety, and Intellectual Property

Legal and ethical considerations

Ethical issues

PharmaCARE intentionally bypassed the Food and Drug Administration when it established CompCARE a compounding pharmacy. This was done in order to avoid FDA scrutinization, which indicates that the company was aware of the side effects that the drug would have on patients. By evading FDA scrutiny and approval, PharmaCARE was able to sell the new formulation on a prescription basis without the need to seek approvals. CompCARE was not supposed to market directly to consumers, but it still conducted direct marketing to consumers and hospitals. Furthermore, the company encouraged doctors to fax them lists of fictitious patient names. This was done to demonstrate that the company was not selling directly to consumers, but rather it was doctors who were prescribing the drug to the patients.

When reports started surfacing indicating that the drug was causing heart attacks, the company did not remove the drug from the market. The company ignored the data and continued to market the drug without informing patients on the side effects of the drug (Halbert & Ingulli, 2011). This was ethically wrong because the company is ethically required to let patients know of the…… [Read More]

Sources:
Halbert, T., & Ingulli, E. (2011). Law and ethics in the business environment. Boston, MA: Cengage Learning.

Kim, Y.K., Lee, K., Park, W.G., & Choo, K. (2012). Appropriate intellectual property protection and economic growth in countries at different levels of development. Research policy, 41(2), 358-375.
View Full Essay

Dietary Pills and Dietary Supplements

Words: 2207 Length: 7 Pages Document Type: Essay Paper #: 78892272

Any weight loss, say doctors, is good weight loss. If there is some minor contribution the medication gives to the whole process, then that's positive. If taken strictly according to instructions, at worst, diet pills are harmless for the most part.

Effects of Dietary Supplements

The FDA regulates dietary supplements only in that it is required to ensure their safety. A manufacturer is not required to register a supplement or have it approved prior to going to market with it. They must only make certain the product is safe. It is the FDA's post-sales responsibility to keep them safe. Manufacturers must ensure that the label on the product is accurate and not misleading in any way.

There are definite benefits in taking dietary supplements per directions. They can assist anyone in obtaining nutrients not consumed through a balanced diet. And some can reduce the risk of certain diseases even though, by FDA regulation, they cannot claim to have any effect on disease at all. Those who have taken certain supplements, like Vitamin C, over many years will testify to their effectiveness in reducing the severity of the common cold as one example.

The risk with dietary supplements is that they…… [Read More]

References:
Foodanddiet.com. "pills." n/d. Foodanddiet.com. 19 July 2009 .

Saper, R.B., D.M. Eisenberg and R.S. Phillips. "Common Dietary Supplements for Weight Loss." 1 November 2004. American Academy of Family Physicians. 19 July 2009 .
View Full Essay

Energy Drinks Should the Powerful

Words: 1145 Length: 3 Pages Document Type: Essay Paper #: 28675408

The Living Essentials company claims it markets its high-powered beverage (which is sold in a 2-oz bottle as a "shot") to "…hardworking adults who need an extra boost of energy" (Meier, p. 2).

Another article in the respected New York Times reports that in addition to the 13 fatalities linked to 5-Hour Energy, another 5 deaths have been linked to "Monster Energy" (Meier, 2012). These data were released by the FDA in November, 2012, because, according to spokeswoman Shelly Burgess, the FDA is making "…an effort to be transparent" (Meier, p. 1). While the FDA did not officially find the product at fault -- at this point there are linkages but no empirical proof that the deaths were a direct result of consuming the energy drinks -- Burgess added that if a "relationship between the consumption of the product and harm" can be proved, the FDA will take "appropriate action to reduce or eliminate the risk" (Meier, p. 1).

(Logos) Can these reports of negative health impacts linked to energy drinks be believed -- and are the manufacturers worried about their profits and their image? One sure and logical way to determine that a company is running scared and trying…… [Read More]

Works Cited:
Retrieved March 6, 2013, from http://www.nytimes.com. 2012.

Meier, Barry. "F.D.A. Post Injury Data for 3 Drinks." The New York Times. Retrieved March 6, 2013, from http://www.nytimes.com. 2012.
View Full Essay

Safety as Prescribed by the

Words: 950 Length: 3 Pages Document Type: Essay Paper #: 58233193

S. Department of Health and Human Services et al., 2006). This first study will involve limited human exposure and extreme caution.

Most significantly, the study itself has to be based on sound scientific principles with a thorough knowledge of the properties of the chemical, and the potential results on the human subject. Standard clinical safety evaluations will include serial assessment of patient symptoms, physical signs, and clinical laboratory tests amongst other tests monitoring possible adverse effects. These tests will be of sufficient duration in order to catch potential negative effects. Safety hazards for patients and health care workers during and after administration of the radio labeled product will also be identified, evaluated and appropriately managed.

Finally, as prescribed by Section 505(d) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 355(d)), adequate tests must be taken on the drug first before applying to a human individual. The drug must be FDA approved, before sponsor is allowed to proceed.

4) micro dosing: its benefits.

Since the drug can potentially be lethal, it is important that a repeat-dose pattern be applied (e.g. Of 14-28 days duration) with the patient being monitored throughout. This also prevents possible adverse effects occurring…… [Read More]

References:
Farde, L. et al., 2007 Using Positron Emission

Tomography (PET) microdosing. Focus, The Organisation for Professionals in Regulatory Affairs,1-8
View Full Essay

Integrating Theory and Needs Assessment

Words: 1864 Length: 6 Pages Document Type: Essay Paper #: 76917577

Integrating Theory and Needs Assessment

A major challenge that a number of health care facilities are facing is accidents related to medical devices. This is from many providers becoming overwhelmed with larger amounts of patients. As a result, the odds have increased of overworked staff members making some kind of error. Evidence of this can be seen in a study that was conducted by the Food and Drug Administration (FDA) along with the Consumer Product Safety Commission (CPSC). They found that between 1999 and 2000 there was a total of 454,383 injuries. ("Estimated 454,383 People," 2004) To deal with these issues the FDA has implemented the MedSun project. This was launched in 2002 with the regulators working in conjunction with hospitals to reduce the number of errors from medical devices. Moreover, the program is built upon the principals of the Safe Medical Devices Act of 1990, the Medical Devices Amendments of 1992 and state regulations. ("Medical Devices," 2012)

In the case of Patton Fuller Community Hospital, there is a $25,000.00 grant that was awarded to the facility. The purpose is to research and implement safety procedures that are in compliance with the MedSun project. To fully understand how this can…… [Read More]

Sources:
Estimated 454,383 People. (2004). News Medical. Retrieved from:  http://www.news-medical.net/news/2004/09/10/4655.aspx 

Medical Devices. (2012). FDA. Retrieved from: http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm112683.htm
View Full Essay

Government Created a Committee an Electronic Health

Words: 985 Length: 3 Pages Document Type: Essay Paper #: 3030372

Government Created a Committee

An electronic health record is a digital record of a patient's health information generated from every medical visit a patient makes. This information includes the patient's medical history, demographics, known drug allergies, progress notes, follow up visits, medications, vital signs, immunizations, laboratory data and radiological reports. The EHR automates and streamlines a clinician's workflow. (Himss, 2009)

Due to the multiple advantages of an EHR, health care agencies have been aiming to push up this technology. In 2004, the FDA approved of an implantable EHR microchip into patients. Each microchip has a specific code which is identified through sensors. The device is implanted under the skin, in the back of the arm, requiring a twenty minute procedure, without needing the use of sutures. ("Fda approves computer," 2004)

According to the Center for Disease Control and Prevention, deaths due to preventable medical errors rank as the fifth most common cause of death. (CDC, 2011) These errors can be attributed to human factors, the complexity of medicine itself and to system failure. Exhaustion and fatigue due to long work hours, unfamiliar settings, time pressures, stress and inability to acknowledge the severity of a certain given set of signs and…… [Read More]

Bibliography:
CDC. (2011, October 24). Deaths and mortality. Retrieved from  http://www.cdc.gov/nchs/fastats/deaths.htm 

Fda approves computer chip for humans. (2004, October 13). Retrieved from http://www.msnbc.msn.com/id/6237364/ns/health-health_care/t/fda-approves-computer-chip-humans/
View Full Essay

Alzheimer's Disease The Onset as

Words: 3283 Length: 8 Pages Document Type: Essay Paper #: 31971086

What is worth noting here is the fact that behavior disturbances, ranging in severity from repeated questioning to physical violence, are common (National Institute of Mental Health, 1989).

It is unclear whether Alzheimer's disease represents a single entity or several variants. Some experts believe that there are distinct subtypes of Alzheimer's disease, such as Lewy body disease (in which the signs of Parkinson's disease, visual hallucinations or alterations in alertness or attention, or all of these symptoms, are conspicuous) and frontotemporal dementia (in which disinhibition, misconduct or apathy, or all of these signs, are prominent). The well-established risk factors for Alzheimer's disease are age, a family history of the disease and Down syndrome (National Institute of Mental Health, 1989).

Confusions about Alzheimer's Disease and the Need for Alternative Actions

There have been numerous studies conducted in relation to Alzheimer's disease. At the same time, there are a number of reports which revealed about the symptoms, treatments and/or prevention approaches that can be done for the disease. but, it cannot be denied that there are also a number of different disorders and illnesses which are closely related or are significantly similar to the qualities and symptoms of Alzheimer's disease. This is…… [Read More]

Resources:
Advisory Panel on Alzheimer's Disease. Advisory Panel on Alzheimer's Disease. DHHS Pub. No. (ADM) 89-1644, Washington, DC: Supt. Of Docs., U.S. Govt. Print. Off. 1989. (Available from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, GPO S/N -1, $2.25.)

Advisory Panel on Alzheimer's Disease. Second Report of the Advisory Panel on Alzheimer's Disease, 1990. DHHS Pub. No. (ADM) 91-1791, Washington, DC: Supt. Of Docs., U.S. Govt. Print. Off., 1991. (Available from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, GPO S/N -7, $3.00.)
View Full Essay

Marketing Product Safety and Intellectual Property Legal

Words: 2675 Length: 9 Pages Document Type: Essay Paper #: 46206825

Marketing

Product Safety, And Intellectual Property

Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual

Ethics and legal issues refer to the morals and principles that govern the behavior and conduct of individuals or organizations. These legal principles and ethics serve to guide and offer directions on how to act or respond when faced with moral dilemmas. Marketing, advertising and product safety are areas of importance to everyone in the community. Production, distribution and use of products or services are areas guided by the laws of the land. The laws function to protect the community from exploitation or mishandling by the participants in the above sectors. In the marketing and advertising framework, the concept of ethics deals with personal moral principles and values. Under this framework, the society understands that laws are values and standards that are enforceable in the court. In the production of goods and services, the laws of the land stipulate the moral principles and guidelines abided by producers.

Discussion

There are many ethical issues relating to marketing, product safety and intellectual property. Under this framework, participants understand that actions considered ethical may not necessarily be legal. Cultural and societal norms may also change perceptions of…… [Read More]

Works Cited:
Ventola, C.L. (2011). Direct-to-Consumer Pharmaceutical Advertising. Journal List, 36 (10), 669-674,681-684. www.ncbi.nlm.nih.gov > Journal List > PT > v. 36 (10); Oct 2011

Hurd, H.M. (1996). Deontology of Negligence, The. BUL Rev., 76, 249.
View Full Essay

Cranberries Vaccinium Macrocarpon Are Indigenous

Words: 1750 Length: 5 Pages Document Type: Essay Paper #: 92232797

A., Reynolds, Y., Rodriguez, G., Camesano, T.A. (2008). Cranberry changes the physicochemical surface properties of E. coli and adhesion with uroepithelial cells. Colloids Surf B. Biointerfaces. 2008 Feb 26 [Epub ahead of print]. Retrieved April 5, 2008 at http://www.ncbi.nlm.nih.gov/pubmed/18378432?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

Mirkin, G. (2003). Acid/Alkaline Theory of Disease Is Nonsense. Quackwatch. Retrieved April 5, 2008 at http://www.quackwatch.org/01QuackeryRelatedTopics/DSH/coral2.html

National Center for Complementary and Alternative Medicine (NCCAM). Cranberry. Retrieved April 5, 2008 at http://nccam.nih.gov/health/cranberry/

Natural Standard Research Collaboration (2006). Cranberry. MedlinePlus. Retrieved April 6, 2008 at http://www.nlm.nih.gov/medlineplus/druginfo/natural/patient-cranberry.html

Raz, R., Chazan, B., Dan, M. (2004). Cranberry juice and urinary tract infection. Clin Infect Dis. 2004 May 15;38(10):1413-9. Epub 2004 Apr 26. Retrieved April 5, 2008 at http://www.ncbi.nlm.nih.gov/pubmed/15156480?ordinalpos=3&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

Schmidt, D.R. & Sobota, a.E. (1988). An examination of the anti-adherence activity of cranberry juice on urinary and nonurinary bacterial isolates. Microbios. 1988;55(224-225):173-81.

Sobota, a.E. (1984). Inhibition of bacterial adherence by cranberry juice: potential use for the treatment of urinary tract infections. J Urol. 1984 May;131(5):1013-6.

U.S. Food and Drug Administration (2007). Frequently Asked Questions About Medical Foods. Retrieved April 5, 2008 at http://www.cfsan.fda.gov/~dms/medfguid.html… [Read More]

Sources:
The Cranberry Institute. Emerging research. Retrieved April 5, 2008 at http://www.cranberryinstitute.org/emerging.htm

Duthie, S.J., Jenkinson, a.M., Crozier, a., Mullen, W., Pirie, L., Kyle, J., Yap, L.S., Christen, P., Duthie, G.G. (2006). The effects of cranberry juice consumption on antioxidant status and biomarkers relating to heart disease and cancer in healthy human volunteers. Eur J. Nutr. 2006 Mar;45(2):113-22. Epub 2005 Jul 20. Retrieved April 5, 2008 at http://www.ncbi.nlm.nih.gov/pubmed/16032375?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_Discovery_RA
View Full Essay

Market Driven Management

Words: 25695 Length: 75 Pages Document Type: Essay Paper #: 32150042

Pharmaceutical industries have to operate in an environment that is highly competitive and subject to a wide variety of internal and external constraints. In recent times, there has been an increasing trend to reduce the cost of operation while competing with other companies that manufacture products that treat similar afflictions and ailments. The complexities in drug research and development and regulations have created an industry that is subject to intense pressure to perform. The amount of capital investment investments required to get a drug from conception, through clinical trials and into the market is enormous. The already high-strung pharmaceutical industry is increasingly investing greater amounts of resources in search of the next "blockbuster" drug that can help them gain market position and profits. Laws, regulations and patents are important to the industry while spending billions of dollars in ensuring the copyright of their products.

It is the intention of this thesis to study the ability of Sanofi-Synthelabo-Dubai, an affiliate of Sanofi-Synthelabo a French multinational pharmaceutical company, in creating an effective and productive market for the products of the company in the Persian Gulf region. The company first desires to concentrate its efforts in the United Arab Emirates (U.A.E.) is first…… [Read More]

View Full Essay

People in Every Walk of

Words: 766 Length: 2 Pages Document Type: Essay Paper #: 71668136

Instead, the research shows that the faster pace of the review process was due to where financial resources went -- to FDA staffing -- not where it came from. The more funding for review scientists there is, the more scientists are on staff, and more work gets completed at a faster rate. The study found that the decrease in turnover time from application submission to completed review began a few years before the passage of the Prescription Drug User Fee Act, thus before the collection of those user fees started (Carpenter et al., 2003).

The question for us to consider is whether the increased efficiency observed by Carpenter et al. means that the FDA is moving back toward a Type I error orientation from the Type II orientation observed by Miller et al. Viewing the drug review process along the dimension of rate of review alone might suggest that a Type I error orientation is taking hold again in the agency. Drugs are being approved faster, suggesting less examination for potentially harmful side effects. However, if the number of qualified review scientists is increasing due to greater resources being put toward staffing, then there is an increase along the manpower/man-hour…… [Read More]

Resources:
Carpenter, D., Chernew, M., Smith, D.G., & Fendrick, a.M. (2003, December 17). Approval

times for new drugs: does the source of funding for FDA staff matter? Health Affairs, w3
View Full Essay

Medication Errors

Words: 1363 Length: 4 Pages Document Type: Essay Paper #: 95239743

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 possibility to drug errors, either through a fault of their own, or from suppliers or pharmacists that supply them. All medication errors must be reported to the Food and Drug Administration. This agency keeps records of the types of drug errors that occur, with the intention of using them as a tool to improve patient safety on all levels (U.S. FDA). This study will explore many facets of medication errors and will present a review of a video on medication errors from the ISMP website. The purpose of this study is to gain a better understanding of medication errors and ways to minimize them in any medical setting.

A medication error is defined as an event that is preventable and that can cause inappropriate medication use for a patient while the medication in under the control of a health care professional (NCCMERP). Medication errors that are a result of patient error do not fall under the same category and…… [Read More]

View Full Essay

Pharma Parallel Trade

Words: 1456 Length: 3 Pages Document Type: Essay Paper #: 7055403

Healthcare

Making Prescription Drugs Affordable?

Parallel Trade and the Pharmaceutical Industry

The skyrocketing cost of prescription drugs remains one of the most contentious issues in America. In this presidential election year, especially, politicians are continually debating ways to make life-saving drugs more affordable. Alone in the world, the United States prohibits the free importation of prescription medications from abroad. Yet, as is so often pointed out by those in favor of changing the law, such drugs are nearly always much less expensive in foreign countries - even medicines that are actually manufactured by American corporations. Of central importance in the argument is the precise rationale for current pricing levels. The pharmaceutical companies and their allies claim that high prices are necessary to finance the continuing innovation of American medicine. Foreign nations, they say, artificially control drug costs, thereby depriving corporations of the sizeable funds required for new research. New medications and treatments are extremely costly to test and to develop, and it is largely because of foreign governments and their socialized healthcare systems that American companies - and therefore Americans - must bear the brunt of these expenses. The development of new, life-saving treatments, insist these American manufacturers, would grind…… [Read More]

View Full Essay

Legal and Ethical Considerations in Marketing Product Safety and Intellectual Property

Words: 3091 Length: 10 Pages Document Type: Essay Paper #: 88383960

Marketing, Product Safety, and Intellectual Property

Ethical issues relating to marketing and advertising, intellectual property, and regulation of product safety

Various organizations often find themselves in the wrong side of the law when undertaking their various business practices relating to marketing and advertisement. It is the desire of every company to have its product known to as many consumers as possible. This often drives them to employ diverse marketing and advertisement strategies that raise some critical ethical issues. The same also applies to the protection of someone's intellectual property and enhancing product safety. This study focuses on deceit, unfairness, and advertising and children as some of the critical ethical issues related to marketing and advertising, intellectual property, and regulation of product safety

Deceit

The Federal Trade Commission is a government branch established to battle deception in advertising. As illustrated in the FTC Act of 1914, the FTC is answerable for controlling unreasonable practices in advertising. Moreover, the FTC was also empowered to manage deceptive or industrially unjustifiable advertisements. Working within the court frameworks, magistrates of the FTC hear cases with respect to violations of the FTC Act. The FTC is also answerable for making guidelines intended to counsel advertisers on…… [Read More]

References:
Cheeseman, H.R. (2010). The legal environment of business and online commerce: Business ethics, e-commerce, regulatory, and international issues. Upper Saddle River, N.J: Pearson/Prentice Hall.

Dukes, M.N.G. (2006). The law and ethics of the pharmaceutical industry. Amsterdam: Elsevier.
View Full Essay

Health Concerns in the Food

Words: 1396 Length: 5 Pages Document Type: Essay Paper #: 29408852

In the UK for instance, there are no guidelines on the issue of nutritional labeling. In some cases nutritional information is ether missing totally or is present in a form which is too complex to be comprehended by the general public.

Therefore, the ongoing discussion between the industry players, health groups and regulators has a focus on making nutritional labeling compulsory as well as making the current system simpler to read and understand. This would the enable the consumers to make their own independent judgments on the type of food that they would like to purchase.

Several proposals have been advanced by the health regulators and watch groups. They include the placing of warning on food and beverages with high energy density as well as linking of the calorie consumption to the energy output by effectively stating how much exercise would be needed to burn off the 'extra' calories in a given serving of a product.

It is worth noting that the food and beverage manufacturers are notorious of arguing that they are never directly responsible for the rise in obesity rates. They blame the consumer's personal eating habits. Well this is pure hogwash because they have the responsibility from…… [Read More]

Bibliography:
Ethical Investment Research Services. Obesity concerns in the food and beverage industry (2006) <  http://www.eiris.org/files/research%20publications/seeriskobesityfeb06.pdf >

Greene, Michael ., Menu labeling laws: the right to nutritional information? Prepared as an academic requirement for the agricultural law course at the Pennsylvania state university's Dickinson school of Law Spring semester (2010)
View Full Essay

Alliance Strategy Analysing the Continuous

Words: 783 Length: 2 Pages Document Type: Essay Paper #: 34210009

" Concerning the type of complementary strategic alliance, it is a horizontal one, because it is formed "when partners who agree to combine their resources and skills to create value in the same stage of the value chain," it is focused "on long-term product development and distribution opportunities" and "the partners may become competitors which requires a great deal of trust between the partners."

The answer to the second question is "no," it's not a "competition response strategy" because the two companies are not really competitors, even if the profile for both company is pharmaceutical. Excel research can be consider in this case as an ally, a support for Century Pharmaceuticals, and even as a consultancy company that works for C.P.

The answer to the third question is "yes," it can be an" uncertainty reducing strategy" because if it functions as it is established, it can reduce the uncertainty about the period of time for the new products to get on the market and also to discover new unmet needs in dermatology and other therapeutic arenas, all of them at lower cost.

The answer to the fourth question is that it can be a competition reducing strategy if this strategy…… [Read More]

References:
1. Hitt Michael a., Ireland R. Duane, Hoskisson Robert a. "Cooperative Strategy." Power Point Presentation by Charlie Cook, the University of West Alabama, and ©2007 Thomson South - Western. All right reserved.

Hitt Michael a., Ireland Duane R., Hoskisson Robert a."Cooperative Strategy" ppt, pg. 9-8
View Full Essay

Sucromate Being a Cattle Breeder

Words: 1270 Length: 4 Pages Document Type: Essay Paper #: 45113197

There is proper way of using Sucromates. Firstly, we need to shake it well before use. One dose accounts for 1 ml of Sucromate, which is to be injected 48 hours before desired ovulation. Sucromate Equine is a suspension of deslorelin and so with the passage of time it will settle down (Equine, pg. 9). Therefore, for this we need to warm the product for atleast 2 minutes so that it can reach room temperature. Warming is done by rolling the vial between two palms. We should at least wait for 30 more minutes by keeping the vial at room temperature. After this, we need to shake the vial forcefully one minute before use. Then we inject 1 ml of the vial in the neck through an intra-muscular injection.

Sucromate has proven to be quite effective as it advances the ovulation process in the mares within 48 hours after the dosage is given. This result has been achieved in 90% of the cases where mares were given the same treatment. After this mare, ovaries were examined with the help of rectal palpation and with the help of ultra sound every day once the dose is given. The time to ovulation…… [Read More]

Sources:
Bioniche. "Bioniche Obtains Exclusive U.S. Rights to Equine Reproductive Product from CreoSalus." 30-11 2010. Bioniche. 18-09 2012 .

Equine, Sucromate. "SucroMate Equine." 4-07 2011. SucroMate. 18-09 2012 < http://www.sucromate.com/ >.
View Full Essay

Business Law During the Consumer Movement of

Words: 1307 Length: 4 Pages Document Type: Essay Paper #: 49860033

Business Law

During the consumer movement of the 1960s and 1970s, Congress enacted a substantial amount of legislation to protect "the good of the people." There is only one problem with consumer protection laws -- they are slow to react and even harder to enforce. As a result of this situation, corporations are allowed to profit at the expense of consumers' health. The resistance comes in a number of stages. The first is denial of the problem, wherein the corporations argue that there is not enough evidence to link their products with the negative outcomes that are being reported. Then there is the lobbying that causes politicians to defer action until a later date, or ignore the call to action altogether. Too often, when statutes are enacted, corporations fight them to the end, resulting in flawed legislation that either has loopholes, require interpretation from the judicial branch or is difficult to enforce. As a result, consumer protections are subsumed to corporate interests.

There are many examples of this over the past few decades. A recent example would be Republican efforts to water down the role of the Consumer Financial Protection Bureau, something that will allow financial corporations -- already responsible…… [Read More]

Works Cited:
Bray, G., Nielsen, S. & Popkin, B. (2004). Consumption of high-fructose corn syrup in beverages may play a role in the epidemic of obesity. The American Journal of Clinical Nutrition. Vol. 79 (4) 537-543.

Goldberg, C. & Zimmerman, R. (2011). What's making us fat? Researchers put food additives on suspect list. Common Health. Retrieved April 11, 2012 from  http://commonhealth.wbur.org/2011/08/food-additives-obesity 
View Full Essay

Tylenol Case Analysis Johnson and

Words: 1160 Length: 4 Pages Document Type: Essay Paper #: 83393004

Johnson and Johnson issued a public relations response immediately naming their number one priority: to aggressively protect any consumer from the potential hazards that may be present in any of their family of products.

Symptoms of the Problem -- Quickly, the crisis reached epic nationwide coverage. The panic that ensued, somewhat as the result of the twenty-four hour media coverage, fueled this panic into a frenzy. One hospital in Chicago, for instance, received 700 calls in one day; while Johnson and Johnson received averaged almost 150 calls per day. Across the country people were admitted into hospitals on suspicion of cyanide poisoning (Tifft, 18). Johnson and Johnson worked rapidly and decisively with the media to disseminate information. When the news spread, copycat criminals began to tamper with the products on the shelves of stores, which only deepened the crisis. Indeed, the FDA confirmed more tampering had taken place, but this did not actually reach the public until much later, the final figure actually 36 units (Church, 27). However, the Food and Drug Administration counted a total 270 incidences of possible product tampering (Kaplan, 1998).

As one would expect, Tylenol's sales and market share plummeted once the crisis was announced. Since…… [Read More]

View Full Essay

Cell Phones Are Responsible for

Words: 900 Length: 3 Pages Document Type: Essay Paper #: 42665802

A significant portion of the information provided supports that there is cause for concern but there is no significant relationship between cell phones and brain cancers.

Other hypothesis that could have been tested could concern effects on skin by the heat emitted from the radiation given off by antennas on cell phones. The article appears to be rather inclusive, and therefore leave little room for misinterpretation. There were so many instances where it was easy to believe everything you read without questioning it, especially when you have an article that is written regarding information reported by the FDA, with the support and backing of various doctors. It is evident that when there is cause for concern it is important to research and determine ways to correct the problem. One of the reasons that radiation and cell phones has become such a mute issue is due to technology. (Nordenberg) the article explains that technology is one of the primary reasons why it is difficult to assess the effects of radiation in cell phones. Cell phones are constantly changing and improving in safety and efficiency. Therefore, it is difficult to use this as a variable in a study with any consistency.

It…… [Read More]

References:
Nordenberg, Tamar. Cell Phones and Cancer: No Clear Connection. FDA Consumer magazine 2000. pp. 1-5
View Full Essay

Pharma Joan Busfield N D Explores

Words: 1293 Length: 4 Pages Document Type: Essay Paper #: 90770935

Demand is dependent on the frequency of a condition in the population. This number, for most conditions, is generally known. Thus, the equilibrium point can be determined that would deliver the cost recovery and markup pharma companies seek, without allowing costs to escalate to gouging levels. The problem is that once the monopoly has been granted there are no serious cost controls beyond market controls.

There are two problems with this. The first is that without cost controls, it is difficult to improve bargaining power. First, buyers have little bargaining power because most buyers -- even insurance companies -- lack size to bargain over prices. Only Medicare and Medicaid have the size to drive prices down, because pharma companies are dependent on their money even with the monopoly. The second is that there is information asymmetry, which reduces the bargaining power of buyers. Again, only the largest and most sophisticated buyers will have any chance of determining the "right" price to pay for a drug, and everyone else will essentially be price-takers. For conditions where there are few if any substitutes, almost every buyer will be a price-taker. Thus, the conditions are ripe for abuse of monopoly power.

Where abuse…… [Read More]

Sources:
Busfield, J. (no date). Pills, power, people. In possession of the author

Abraham, J. (no date). The sociological concomitants of the pharmaceutical industry and medications. Handbook of Medical Sociology. In possession of the author.
View Full Essay

Sexual Liberation in Addition to Sexual Intercourse

Words: 1334 Length: 3 Pages Document Type: Essay Paper #: 51575450

Sexual Liberation

In addition to sexual intercourse and its variations, sexual liberation refers to the universe of human issues affecting all genders. America was propelled from the sexual enslavement of the 1950's to considerably increased sexual liberation of the 1980's and beyond. Two significant events of the 1960's that contributed to sexual liberation were the FDA approval of The Pill and the birth of the Women's Liberation Movement.

Sexual Suppression of the 1950's

An examination of liberation should begin with the sexual slavery of the 1950's. By current standards, sexual suppression was a numbing fact of 1950's America, particularly for women. For example, the legendary "Good Wife's Guide" (Housekeeping Monthly, 1955) spouts standards that are otherworldly by today's norms. Perhaps its most oppressive statement is "A good wife always knows her place" (Housekeeping Monthly, 1955), though the guide serves up plenty of other now-hilarious goodies. "Assisting" housebound married women in the proper treatment of their husbands, the guide gives such pointers as: "Let him talk first -- remember, his topics of conversation are more important than yours"; "Don't complain if he's late home for dinner or even if he stays out all night"; "Arrange his pillow and offer to take…… [Read More]

References:
Dekkers, O. (1971, December 12). National Women's political caucus. Retrieved on June 15, 2012 from proquest.umi.com Web site: http://proquest.umi.com/pqdweb?index=23&did=659219891&SrchMode=1&sid=4&Fmt=3&VInst=PROD&VType=PQD&RQT=309&VName=PQD&TS=1339792329&clientId=14844

Henry, A. (1978, February 28). Reproductive thinking. Retrieved on June 15, 2012 from proquest.umi.com Web site: http://proquest.umi.com/pqdweb?index=2&did=659235281&SrchMode=2&sid=6&Fmt=3&VInst=PROD&VType=PQD&RQT=309&VName=PQD&TS=1339792863&clientId=14844