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2025 I need a response for the following peers Peer 1 Fast Track is
by adminResponse 14 2025
I need a response for the following peers: Peer 1 Fast Track is an initiative by an agency in the US known as Food and Drug Administration (FDA) to investigate drugs for expedited review to enable development of those that would cure acute diseases, as well as fill in the unmet gaps in the medicinal field. The process of approving a drug to be consumed by human beings takes up to twelve years in the prompt laboratory. Therefore, the FDA ensures that efficient processes during the development of Fast Track drugs are met based on the rules and regulations of the whole initiative. The medical conditions under which a patient is allowed to take such drugs are also critical and vital considerations. In the case of the process of approving and expediting Fast Track drugs, different programs are put in place to review their purpose and efficiency in the subject. One of the major programs that are essential during the development of Fast Track drugs is conducting an in-depth study and understanding of the project so that it follows an effective path before approval (Kesselheim, Wang, Franklin, & Darrow, 2015). Accelerated approvals may also be conducted upon agreement between drug sponsors and FDA. Some of the agreements that may be made before this type of approval are based on the unmet needs present to a demographic regarding the subject, surrogate endpoints that would be scrutinized, and the benefits that the drug would have to the patient population being studied, as well as post-marketing commitments. Fast Track drug regulation starts by adopting and submitting it to the Town Hall website where the executive branch reviews it. Executive branch under the office of the Attorney general reviews the Fast Track before the Cabinet Secretary Governor submits it to the Town Hall. Emails are then sent to Townhall registered users before the review is published. This process takes place within ten days of review submission by the Cabinet Secretary Governor. After the publication, people are given a chance to comment before it is implemented. Any disapproval from one or more members of the standing committee of the Senate, house delegates, a member of the joint commission or ten people from the public cause the Fast Track regulation to serve as a Notice of Intended Regulatory Action. On the other hand, lack of disapproval from any of the titles mentioned above makes the regulation effective after fifteen days. Peer 2. The use of Fast Track drugs is warranted under different conditions. One of the medical conditions that call for the use of such drugs is when there is a serious condition in a particular demographic (Hwang, Darrow & Kesselheim, 2017). Therefore, if there are any positive impacts of using a Fast Track drug, then the approval of administering the cure is given. The approval may be booked under two circumstances. One is the survival factor that the drug can offer while the other regards preventing the disease in the subject from worsening (Hwang et al., 2017). Similarly, a Fast Track drug may be warranted if there is an unmet medical need. Therefore, people are allowed to take such drugs if they treat them or prevent them from contracting a particular disease. Fast Track drugs follow a strict path before being approved to be used. It is done to avoid any health risks that may befall the public by using them. Therefore, the FDA makes life-saving investigational drug therapies by offering expedited drug approval. The process is what is identified as Fast Track in the paper. These drugs pass through reviews before being accepted to be used by people want to manage or prevent a particular disease. Above is the original work if needed: The Food and Drug Administration (FDA) is a U.S. government agency within the Department of Health and Human Services. Its primary role is to protect public health, by ensuring safety and effectiveness of drugs, vaccines, medical devices and food products. There are rigorous steps that may take years, and all these steps must be completed before a drug can be approved. The FDA has made some lifesaving investigational drug therapies available sooner than usual by offering an expedited drug approval process, known as “Fast Track”. I. Discuss the process and regulations of Fast Track. II. Identify which medical conditions warrant the use of “Fast Track” drugs.
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2025 Discuss the process and regulations of Fast Track Strict processes and regulations are considered are
by adminAnswer To Peer, Similarities Less 5%, References 2, APA 6 2025
Discuss the process and regulations of Fast Track Strict processes and regulations are considered are considered by the FDA before the approval of a drug. Moreover, the role of the manufacturing company is very important in that their compliance to ensure that their products and the conditions of their manufacture meet the minimum health requirements. According to Damle et al. (2016), the process and regulations under the provisions of FDA are defined by some aspects of eligibility. For instance, the company in question is required to have many frequent meetings the regulatory body which provides them the opportunity to discuss the development of a drug, and allow the collection of data for the support of approval. The manufacturing company is required to wait for many forms of written communication from the FDA regarding the standards like the design of proposed clinical trials (Damleet al., 2016). It will, therefore, be the role of the company to send the New Drug Application (NDA) to be reviewed by FDA and the eligibility may be confirmed if the criterion utilized is relevant to the stated standards. Identify which medical conditions warrant the use of “Fast Track” drugs. FDA has specific principles which must be met by the manufacturing company which occurs in the forms of medical conditions. On the same note, it is important to note that any newly developed drug is to prevent a condition without current therapy is normally directed at an unmet need. It is therefore expected that the drug in question presents some conditions which may comply with the available health standards (Damle et al., 2016). For example, FDA requires that a drug showing the superior effectiveness and improved effect on the unmet health conditions. Moreover, the regulatory body provides that a drug that is newly developed should be associated with minimum side effects to the users. Furthermore, a drug must address an anticipated or emerging public health need. References Damle, N., Shah, S., Nagraj, P., Tabrizi, P., Rodriguez, G., & Bhambri, R. (2016). FDA’s Expedited Programs and Their Impact on the Availability of New Therapies. Therapeutic Innovation & Regulatory Science , 51 (1), 24-28. doi: 10.1177/2168479016666587 Damle, N., Shah, S., Nagraj, P., Tabrizi, P., Rodriguez, G., & Bhambri, R. (2016). FDA’s Expedited Programs and Their Impact on the Availability of New Therapies. Therapeutic Innovation & Regulatory Science , 51 (1), 24-28. doi: 10.1177/2168479016666587
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2025 Advanced Pharmacology Short term treatment options for asthma in a child include oral corticosteroids which are often used to
by adminAnswer To Peer, Similarities Less 5%, References 2, APA 6 2025
Advanced Pharmacology Short term treatment options for asthma in a child include oral corticosteroids, which are often used to gain prompt control of poorly controlled persistent asthma, or when starting long-term therapy. It is used for short-term (3-10 days) “burst”, broad anti-inflammatory effects. Long-term control medications include corticosteroids to block late-phase reaction to allergen, reduce airway hyper responsiveness, and inhibit inflammatory cell migration and activation. They are the most potent and effective anti-inflammatory medication currently available. Inhaled corticosteroids (ICSs) are used in the long-term control of asthma. Short courses of oral systemic corticosteroids are often used to gain prompt control of the disease when initiating long-term therapy; long-term oral systemic corticosteroid is used for severe persistent asthma. Patient education includes teaching parent how to identify triggers, consider a high-efficiency particulate air (HEPA) filter in the bedroom or on the furnace. Although these interventions may reduce pet allergen levels some, they are much less effective than finding the pet a new home. Control cockroaches. Respiratory infections should be treated very quickly when you have asthma, as infections are a common trigger for asthma exacerbations. Preventing illness is a priority and frequent hand washing and keeping immunizations up to date are critical. Compliance with the medication regime will not only help control symptoms but will also keep the asthma more manageable overall. References Banjari, M., Kano, Y., Almadani, S.T. (2018). The relation between asthma control and quality of life in children. International Journal of Pediatrics, 1–6 . https://doi.org/10.1155/2018/6517329 brahim, N. K., Alhainiah, M., & Felmban, O. (2019). Quality of Life of asthmatic children and their caregivers. Journal of Medical Sciences, 35 (2), 1–6. https://doi.org/10.12669/pjms.35.2.686
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2025 Purpose The purpose of this assignment is to provide the student an
by adminCourse Reflection Nursing Leadership And Management 2025
Purpose The purpose of this assignment is to provide the student an opportunity to reflect on selected RN-BSN competencies acquired through the NUR4827 course. Course Outcomes This assignment provides documentation of student ability to meet the following course outcomes: – The student will be able to identify the different roles of leadership and management in the nursing field. – The student will be able to analyze and apply the leadership and management role into the nursing profession. Points This assignment is worth a total of 100 points (10%). Due Date Submit your completed assignment under the Assignment tab by Sunday 11:59 p.m. EST of Week 15 as directed. Requirements 1. The Course Reflection is worth 100 points (10%) and will be graded on quality of self-assessment, use of citations, use of Standard English grammar, sentence structure, and overall organization based on the required components as summarized in the directions and grading criteria/rubric. 2. Follow the directions and grading criteria closely. Any questions about your essay may be posted under the Q & A forum under the Discussions tab. 3. The length of the reflection is to be within three to six pages excluding title page and reference pages. 4. APA format is required with both a title page and reference page. Use the required components of the review as Level 1 headers (upper and lower case, centered): Note: Introduction – Write an introduction but do not use “Introduction” as a heading in accordance with the rules put forth in the Publication manual of the American Psychological Association (2010, p. 63). a. Course Reflection b. Conclusion Preparing the Reflection The BSN Essentials (AACN, 2008) outline a number of healthcare policy and advocacy competencies for the BSN-prepared nurse. Reflect on the NUR4827 course readings, discussion threads, and applications you have completed across this course and write a reflective essay regarding the extent to which you feel you are now prepared to: 1. “Apply leadership concepts, skills, and decision making in the provision of high-quality nursing care, healthcare team coordination, and the oversight and accountability for care delivery in a variety of settings. 2. Demonstrate leadership and communication skills to effectively implement patient safety and quality improvement initiatives within the context of the interprofessional team. 3. Demonstrate an awareness of complex organizational systems. 4. Demonstrate a basic understanding of organizational structure, mission, vision, philosophy, and values. 5. Participate in quality and patient safety initiatives, recognizing that these are complex system issues, which involve individuals, families, groups, communities, populations, and other members of the healthcare team. 6. Apply concepts of quality and safety using structure, process, and outcome measures to identify clinical questions and describe the process of changing current practice. 7. Promote factors that create a culture of safety and caring. 8. Promote achievement of safe and quality outcomes of care for diverse populations. 9. Apply quality improvement processes to effectively implement patient safety initiatives and monitor performance measures, including nurse-sensitive indicators in the microsystem of care. 10. Use improvement methods, based on data from the outcomes of care processes, to design and test changes to continuously improve the quality and safety of health care. 11. Employ principles of quality improvement, healthcare policy, and cost-effectiveness to assist in the development and initiation of effective plans for the microsystem and/or systemwide practice improvements that will improve the quality of healthcare delivery. 12. Participate in the development and implementation of imaginative and creative strategies to enable systems to change.” (AACN, 2008, p.14). Reference: American Association of Colleges of Nursing [AACN]. (2008). The essentials of baccalaureate education for professional nursing practice. Washington, DC: Author.
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