Federal Drug Administration Essay Paper
Order ID 53003233773 Type Essay Writer Level Masters Style APA Sources/References 4 Perfect Number of Pages to Order 5-10 Pages
Federal Drug Administration Essay Paper
This is an example of an ethical dilemma. Under the Federal Drug Administration (FDA), manufacturers are not supposed to disclose the results of medical research to the public domain (Kesselheim& Mello, 2007). On the other hand, manufacturers have a moral obligation to disclose the research information to the public, especially since the drug is now linked to cancer.
As the manufacturer, I would voluntarily disclose the study information to the public but under conditions. The FDA requires the drug manufacturers to undergo a long, expensive, and a multistep process that takes many years and includes numerous clinical on human subjects (Unlu, 2009). The manufacturer then files for investigational new drug application with the FDA. After the approval, the manufacturer continues with the human trials before filing a New Drug application (Unlu, 2009). In summary, the process of manufacturing drugs is laborious and time-consuming. All along, manufacturers pay for their cost of research data generation (Kesselheim& Mello, 2007). For this reason, research data should be kept confidential.
I would, therefore, disclose information that will not put our organization at risk. I would contact the Federal Drug Administration and ask for guidance on the best way forward before disclosing the information. Disclosing the research data promote public interests by getting rid of costs that result from keeping research data out of reach of the public. Unlu (2009) found that Merck did not disclose research information about its Vioxx’s after reports indicated that the drug was posing cardiovascular risks to patients. Disclosing the research information would boost the customers’ trust, a move that would make the company earn more. Since it is only preliminary research, it will allow the customers to evaluate the effectiveness of the drug and make an informed decision on whether to continue using our products (Kesselheim& Mello, 2007).
In summary, I would be more than willing to disclose the research information concerning our product since it is only preliminary research. I would, however, ensure that I protect the confidential information that would put the company at risk of losing the trade secrets.
According to me I would volunteer from myself and will disclose the information. Based on two grounds I would do that and if the information is ethical then the information can be disclosed to the customers. Based on the research from the history the breast implants which are covered here in this text will not be difficult for spotting a similar pattern here. Based on the full disclosure only the choices would be made by the buyers and they will require whole market information.
About the drugs, there will be information in the firms, and this will not be available or the purchasers. The final disclosure needs to be made not only from the ethical perspective, but they should also take from the litigation perspective. Here are some of the allegations which are raised on the fertility drugs that result in ovarian cancer. Based on the research we can to know that these drugs are been used by most women where this results in cancer (Kravdal & et al, 2017).
Correlation between Ovarian Cancer and Fertility Drugs
In the united states, most of the women have been suffered due to this drug and it causes cancer. Based on the researchers by many people I came to know that due to infertility this drug leads to cancer and harms many women’s health and increases the risks. For this problem there should be a treatment and infertility increased the need of treatment where all other health care systems are trying to play with the people’s health using some fertility drugs.
This raised a lot of consequences. The factor per se of infertility has been leading this cancer issue because they are using this fertility drug as there medication and this has come to know on the study research. To Vitro fertilization, this cancer is mainly related to and the changes which are made in this increase the fertilization were in increases the risks (QingAn & et al, 2018).
Cancer will posses to everybody through the use of the fertility drugs unusually where this is one of the drugs which decreases the fatal of a person (Roti & et al, 2014).
Federal Drug Administration Essay Paper
QUALITY OF RESPONSE NO RESPONSE POOR / UNSATISFACTORY SATISFACTORY GOOD EXCELLENT Content (worth a maximum of 50% of the total points) Zero points: Student failed to submit the final paper. 20 points out of 50: The essay illustrates poor understanding of the relevant material by failing to address or incorrectly addressing the relevant content; failing to identify or inaccurately explaining/defining key concepts/ideas; ignoring or incorrectly explaining key points/claims and the reasoning behind them; and/or incorrectly or inappropriately using terminology; and elements of the response are lacking. 30 points out of 50: The essay illustrates a rudimentary understanding of the relevant material by mentioning but not full explaining the relevant content; identifying some of the key concepts/ideas though failing to fully or accurately explain many of them; using terminology, though sometimes inaccurately or inappropriately; and/or incorporating some key claims/points but failing to explain the reasoning behind them or doing so inaccurately. Elements of the required response may also be lacking. 40 points out of 50: The essay illustrates solid understanding of the relevant material by correctly addressing most of the relevant content; identifying and explaining most of the key concepts/ideas; using correct terminology; explaining the reasoning behind most of the key points/claims; and/or where necessary or useful, substantiating some points with accurate examples. The answer is complete. 50 points: The essay illustrates exemplary understanding of the relevant material by thoroughly and correctly addressing the relevant content; identifying and explaining all of the key concepts/ideas; using correct terminology explaining the reasoning behind key points/claims and substantiating, as necessary/useful, points with several accurate and illuminating examples. No aspects of the required answer are missing. Use of Sources (worth a maximum of 20% of the total points). Zero points: Student failed to include citations and/or references. Or the student failed to submit a final paper. 5 out 20 points: Sources are seldom cited to support statements and/or format of citations are not recognizable as APA 6th Edition format. There are major errors in the formation of the references and citations. And/or there is a major reliance on highly questionable. The Student fails to provide an adequate synthesis of research collected for the paper. 10 out 20 points: References to scholarly sources are occasionally given; many statements seem unsubstantiated. Frequent errors in APA 6th Edition format, leaving the reader confused about the source of the information. There are significant errors of the formation in the references and citations. And/or there is a significant use of highly questionable sources. 15 out 20 points: Credible Scholarly sources are used effectively support claims and are, for the most part, clear and fairly represented. APA 6th Edition is used with only a few minor errors. There are minor errors in reference and/or citations. And/or there is some use of questionable sources. 20 points: Credible scholarly sources are used to give compelling evidence to support claims and are clearly and fairly represented. APA 6th Edition format is used accurately and consistently. The student uses above the maximum required references in the development of the assignment. Grammar (worth maximum of 20% of total points) Zero points: Student failed to submit the final paper. 5 points out of 20: The paper does not communicate ideas/points clearly due to inappropriate use of terminology and vague language; thoughts and sentences are disjointed or incomprehensible; organization lacking; and/or numerous grammatical, spelling/punctuation errors 10 points out 20: The paper is often unclear and difficult to follow due to some inappropriate terminology and/or vague language; ideas may be fragmented, wandering and/or repetitive; poor organization; and/or some grammatical, spelling, punctuation errors 15 points out of 20: The paper is mostly clear as a result of appropriate use of terminology and minimal vagueness; no tangents and no repetition; fairly good organization; almost perfect grammar, spelling, punctuation, and word usage. 20 points: The paper is clear, concise, and a pleasure to read as a result of appropriate and precise use of terminology; total coherence of thoughts and presentation and logical organization; and the essay is error free. Structure of the Paper (worth 10% of total points) Zero points: Student failed to submit the final paper. 3 points out of 10: Student needs to develop better formatting skills. The paper omits significant structural elements required for and APA 6th edition paper. Formatting of the paper has major flaws. The paper does not conform to APA 6th edition requirements whatsoever. 5 points out of 10: Appearance of final paper demonstrates the student’s limited ability to format the paper. There are significant errors in formatting and/or the total omission of major components of an APA 6th edition paper. They can include the omission of the cover page, abstract, and page numbers. Additionally the page has major formatting issues with spacing or paragraph formation. Font size might not conform to size requirements. The student also significantly writes too large or too short of and paper 7 points out of 10: Research paper presents an above-average use of formatting skills. The paper has slight errors within the paper. This can include small errors or omissions with the cover page, abstract, page number, and headers. There could be also slight formatting issues with the document spacing or the font Additionally the paper might slightly exceed or undershoot the specific number of required written pages for the assignment. 10 points: Student provides a high-caliber, formatted paper. This includes an APA 6th edition cover page, abstract, page number, headers and is double spaced in 12’ Times Roman Font. Additionally, the paper conforms to the specific number of required written pages and neither goes over or under the specified length of the paper.
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