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Essay Instructions: Application: Divisions of the FDA

The FDA is a complex organization with an extremely wide scope of responsibilities, including drugs, biologics, and medical device safety and research. The agency also oversees the public safety of cosmetics, foods, radiation-emitting electronic products, and veterinary products.

The Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Drug Evaluation and Research (CDER) are the three divisions of the FDA that administer safety of medical products and clinical research studies in their respective specialty areas.

To prepare for this Application Assignment, visit the FDA Organization page at http://www.fda.gov/AboutFDA/CentersOffices/default.htm. Here you will find a link to each division of the FDA. Review each of three divisions of the FDA that has jurisdiction over medical products. Search each site for activities currently underway that are based on clinical research studies. An example would be the clinical trials involving the Gardasil? vaccine.

To complete this Application Assignment, write a 2- to 3-page paper concerning an activity currently underway by one of these organizations that is of interest to you. Potential topics could include recalls for drugs or devices based on clinical research findings, an agency review of adverse events for a drug or medical device, or an activity about a current health issue that is somewhat controversial in the public sector.

Submit your Application Assignment to the Dropbox by Day 6.

Your written assignments must follow APA guidelines. Be sure to support your work with specific citations from this week?s Learning Resources and additional scholarly sources as appropriate. Refer to the Pocket Guide to APA Style to ensure your in-text citations and reference list are correct.

Save your Application as a ".doc" or ".rtf" file with the filename "APP6+last name+your first initial." For example, Sally Ride?s assignment filename would be "APP6RideS". Use the Submit an Assignment link, choose the Week 6: Application basket, and then add your Application as an attachment.

Essay Instructions: The purpose of this assignment is to decide what steps needed to take in order to
receive FDA approval for the device you proposed in the business plan project. To save
time and money, you are trying to minimize the amount of approval that is required to
market your device.

I will provide 2-files, 1. my business plan file that show my device idea and 2. the assignment instruction.


thank you
There are faxes for this order.

Customer is requesting that (bolavens) completes this order.

Essay Instructions: Included in my references will be the grading rubric for the paper.

Description of paper: From within any segment of the health care industry, develop a policy change initiative that would have the potential to improve a health system or the health status of individuals or groups. Your focus may be on local or statewide issues, the U.S. as a whole, or on global policy. Select an area related to your professional interests. Describe it in your paper, including a brief historical overview; delineation of population groups to be targeted; research support (as available and relevant); stakeholders and key players; related missions/ philosophy and political considerations; funding opportunities; health disciplines and their roles in your policy; and implementation plans. Be realistic -- that is, take into account costs and funding factors ?" and use knowledge from the course.
Your individual paper should be focused and in depth within the required page limits. Follow the guidelines detailed in the grading rubric. Make sure you understand all of the criteria to be used in grading your paper. The paper will be graded based both on substance & technical writing strength.
Paper length: 7-10 pages. Use APA (5th or 6th ed.) format. Current journals and legitimate websites should be used for your research. Reference page should not be dominated by internet/website references (no more than 35%). This does not include electronic journal references.

My topic is arguing that the FDA should cover botox injections into the bladder for both neurogenic and non-neurogenic bladder issues. The paper must include research on the process for FDA approval and policy setting. Currently, intravesical botox injections are an off-label usage of botox, as it is not approved by the FDA. Due to this reason, many insurance companies will not cover botox injections, despite the amount of research that supports its efficacy. Many of my patients have tried every other avenue of treatment and failed, and insurance will still not cover the botox. A vial of 100 units of botox is roughly $600, and many people require 300 units of botox per injection. Each session of botox injections lasts approximately 6 months. That is $3600 out-of-pocket every year to give a patient a normal life. In today's economy, that is outrageous!
There are faxes for this order.

Essay Instructions: The purpose of this homework assignment is for you to investigate a legislative act that has been modified and has played a role in our health care delivery system. Identify a legislative act that has affected the health care delivery system in the United States. You may want to select a ruling or law that has impacted your personal career. Explain the history of the act, the intent of the act, the reasoning for any modifications, and how it has impacted health care. Please do not use Medicare or Medicaid since this has been examined thoroughly in the textbook and lecture notes. The subject I choose to write about is: Medical devices: FDA Should take steps to ensure that high -risk device types are approved through the most stringent premarket review process. All papers must be a minimum of three typed pages, follow APA format, make sure to include a reference page and title and cover page.