Answer 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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Response 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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Nursing Assessment. 2025

Complex Regional Pain Disorder White Male With Hip Pain BACKGROUND This week, a 43-year-old white male presents at the office with a chief complaint of pain. He is assisted in his ambulation with a set of crutches. At the beginning of the clinical interview, the client reports that his family doctor sent him for psychiatric assessment because the doctor felt that the pain was “all in his head.” He further reports that his physician believes he is just making stuff up to get “narcotics to get high.” SUBJECTIVE The client reports that his pain began about 7 years ago when he sustained a fall at work. He states that he landed on his right hip. Over the years, he has had numerous diagnostic tests done (x-rays, CT scans, and MRIs). He reports that about 4 years ago, it was discovered that the cartilage surrounding his right hip joint was 75% torn (from the 3 o’clock to 12 o’clock position). He reports that none of the surgeons he saw would operate because they felt him too young for a total hip replacement and believed that the tissue would repair with the passage of time. Since then, he reported development of a strange constellation of symptoms including cooling of the extremity (measured by electromyogram). He also reports that he experiences severe cramping of the extremity. He reports that one of the neurologists diagnosed him with complex regional pain syndrome (CRPS), also known as reflex sympathetic dystrophy (RSD). However, the neurologist referred him back to his family doctor for treatment of this condition. He reports that his family doctor said “there is no such thing as RSD, it comes from depression” and this was what prompted the referral to psychiatry. He reports that one specialist he saw a few years ago suggested that he use a wheelchair, to which the client states “I said ‘no,’ there is no need for a wheelchair, I can beat this!” The client reports that he used to be a machinist where he made “pretty good money.” He was engaged to be married, but his fiancé got “sick and tired of putting up with me and my pain, she thought I was just turning into a junkie.” He reports that he does get “down in the dumps” from time to time when he sees how his life has turned out, but emphatically denies depression. He states “you can’t let yourself get depressed… you can drive yourself crazy if you do. I’m not really sure what’s wrong with me, but I know I can beat it.” During the client interview, the client states “oh! It’s happening, let me show you!” this prompts him to stand with the assistance of the corner of your desk, he pulls off his shoe and shows you his right leg. His leg is turning purple from the knee down, and his foot is clearly in a visible cramp as the toes are curled inward and his foot looks like it is folding in on itself. “It will last about a minute or two, then it will let up” he reports. Sure enough, after about two minutes, the color begins to return and the cramping in the foot/toes appears to be releasing. The client states “if there is anything you can do to help me with this pain, I would really appreciate it.” He does report that his family doctor has been giving him hydrocodone, but he states that he uses is “sparingly” because he does not like the side effects of feeling “sleepy” and constipation. He also reports that the medication makes him “loopy” and doesn’t really do anything for the pain. MENTAL STATUS EXAM The client is alert, oriented to person, place, time, and event. He is dressed appropriately for the weather and time of year. He makes good eye contact. Speech is clear, coherent, goal directed, and spontaneous. His self-reported mood is euthymic. Affect consistent to self-reported mood and content of conversation. He denies visual/auditory hallucinations. No overt delusional or paranoid thought processes appreciated. Judgment, insight, and reality contact are all intact. He denies suicidal/homicidal ideation, and is future oriented. Diagnosis: Complex regional pain disorder (reflex sympathetic dystrophy) Decision Point One Select what the PMHNP should do: Savella 12.5 mg orally once daily on day 1; followed by 12.5 mg BID on day 2 and 3; followed by 25 mg BID on days 4-7; followed by 50 mg BID thereafter Amitriptyline 25 mg po QHS and titrate upward weekly by 25 mg to a max dose of 200 mg per day Neurontin 300 mg po BEDTIME with weekly increases of 300 mg per day to a max of 2400 mg if needed Examine Case Study: A Caucasian Man With Hip Pain. You will be asked to make three decisions concerning the medication to prescribe to this client. Be sure to consider factors that might impact the client’s pharmacokinetic and pharmacodynamic processes. At each decision point stop to complete the following: Decision #1 Which decision did you select? Why did you select this decision? Support your response with evidence and references to the Learning Resources. What were you hoping to achieve by making this decision? Support your response with evidence and references to the Learning Resources. Explain any difference between what you expected to achieve with Decision #1 and the results of the decision. Why were they different? Decision #2 Why did you select this decision? Support your response with evidence and references to the Learning Resources. What were you hoping to achieve by making this decision? Support your response with evidence and references to the Learning Resources. Explain any difference between what you expected to achieve with Decision #2 and the results of the decision. Why were they different? Decision #3 Why did you select this decision? Support your response with evidence and references to the Learning Resources. What were you hoping to achieve by making this decision? Support your response with evidence and references to the Learning Resources. Explain any difference between what you expected to achieve with Decision #3 and the results of the decision. Why were they different? Also, include how ethical considerations might impact your treatment plan and communication with clients.

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Project Donna Dubinsky 2025

Project READ THIS ENTIRE DOCUMENT BEFORE YOU BEGIN You are to create a PowerPoint Presentation (75%) and a video (25%). It is an assigned topic. Your topics are at the end of the document with the schedule of presentation. For the PowerPoint you must: · Research your subject · Find photographs SUBJECT You may be assigned an object that has evolved through the years. Tell me how it started and where it is now. Tell me how it has changed, improved and possibly where we might go in the future with this object. Be sure to be true to the subject and don’t go off topic. I don’t need to know how it is used or what it can do. Explain the evolution. For example, MUSIC: Tell me how we’ve come to the digital recordings or digital instruments. I don’t need to know about a specific GENRE like Rock or Classical music. PIONEER You may be assigned a pioneer in the IT/Computing field. Please give some background on this person. What is it that made them a pioneer? Tell me what they have done, what they have achieved (awards, accolades, etc..). If they are alive, what are they doing now and projecting for the future? Be thorough. Below are the criteria for the PowerPoint and Video portions of your presentation. PowerPoint Criteria · Your Presentation should not be your entire research assignment. o USE THE 7X7 RULE § 7 lines per slide (maximum) § 7 words per line (maximum) o This does not mean that all of your slides need to have 7 lines with 7 words o Use key words and/or phrases to make your point o DO NOT crowd the slides with too much text or pictures · Use the NOTES Pages underneath each slide to include some information you are going to talk about if/when presenting in front of an audience. · The purpose of the presentation is to give details, information or teach about a subject. · Be sure that your slides contain both text and pictures o There should not be any slides with pictures only § FORMAT the pictures/images that you’ve used · Be sure to include a slide transition o Use the same transition throughout the presentation o DO NOT make the slides change automatically · Include a footer on all slides, except the Title Slide o Enter your name and your Student ID number · Be sure to submit a PowerPoint Presentation and not a Slide Show. (Be careful on how you save it!) o DO NOT make the slides change automatically o The Presentation MUST have a minimum of 15 slides. § Slide 1: Title § Slides 2 – 14: Presentation § Slide 15: Work Cited, Links, Video Link and resources o INCLUDE A LINK TO YOUR VIDEO (see below) · DO NOT embed your video in the presentation Be sure to add your picture somewhere in the PowerPoint Presentation and in the Video. VIDEO Criteria You will need to go to the Animoto website (click the link) and sign-up for a free account. There are multiple video samples and tutorials on how to use the site. There is a limit of 30 seconds for the video. You MUST use up the entire 30 seconds for your video. You may go over the 30 seconds by up to 10 seconds. Your video is NOT a copy of your PowerPoint Presentation. · You MUST include a picture of yourself either at the beginning (after the title) or at the very end · You MUST include your works cited and resource links · You must include a song(s) · Your video MUST contain some of the research (TEXT), it cannot be pictures only. · The Video MUST be 30 seconds, as there is a limitation to the free web site use. · It is IMPORTANT that you pick and choose the information that will represent your subject matter the best. There should be NO YouTube videos. All your videos need to come from animoto.com

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