Order ID:89JHGSJE83839 | Style:APA/MLA/Harvard/Chicago | Pages:5-10 |
Instructions:
New Drug Application CVT 301
Assignment description: In completing Writing Assignment students will have the opportunity to:
For this assignment, you are a Sr Manager of Regulatory Affairs at a small, emerging biotechnology company that has completed all aspects of development for a combination drug/device product called CVT-301. CVT-301 was developed for treatment of the symptoms of Parkinson’s Disease and your company is now ready to begin preparation for submitting its NDA for CVT-301, also known as Ingria
Your task is to provide a HIGH-LEVEL (see template for guidance on the level of detail that is being requested) outline of the information that must be provided by your company in Modules 1 and 2 of an NDA submission, regarding its drug, CVT-301/Ingria. This will help to align your teams on the content for these modules as you prepare to begin writing! For this task, you will use publicly available information from the FDA Approved Drugs Database (see here: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm). You should conduct a search for “Ingria” and locate the “Approval Date and History, Letters, Labels, Reviews for NDA” tab.
You will use the following documents under “Application Review Files:” • Summary Review: This file provides a high-level summary of the FDA’s entire review of the NDA for Ingria. You can use information from this form to complete your high-level review of Module 1 and parts of Module
See template for details.
this Written Assignment should be comprised of 5-7 pages of content (including references). but NOT Including figures or tables, double-spaced
New Drug Application CVT 301
RUBRIC |
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Excellent Quality 95-100%
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Introduction
45-41 points The background and significance of the problem and a clear statement of the research purpose is provided. The search history is mentioned. |
Literature Support 91-84 points The background and significance of the problem and a clear statement of the research purpose is provided. The search history is mentioned. |
Methodology 58-53 points Content is well-organized with headings for each slide and bulleted lists to group related material as needed. Use of font, color, graphics, effects, etc. to enhance readability and presentation content is excellent. Length requirements of 10 slides/pages or less is met. |
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Average Score 50-85% |
40-38 points More depth/detail for the background and significance is needed, or the research detail is not clear. No search history information is provided. |
83-76 points Review of relevant theoretical literature is evident, but there is little integration of studies into concepts related to problem. Review is partially focused and organized. Supporting and opposing research are included. Summary of information presented is included. Conclusion may not contain a biblical integration. |
52-49 points Content is somewhat organized, but no structure is apparent. The use of font, color, graphics, effects, etc. is occasionally detracting to the presentation content. Length requirements may not be met. |
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Poor Quality 0-45% |
37-1 points The background and/or significance are missing. No search history information is provided. |
75-1 points Review of relevant theoretical literature is evident, but there is no integration of studies into concepts related to problem. Review is partially focused and organized. Supporting and opposing research are not included in the summary of information presented. Conclusion does not contain a biblical integration. |
48-1 points There is no clear or logical organizational structure. No logical sequence is apparent. The use of font, color, graphics, effects etc. is often detracting to the presentation content. Length requirements may not be met |
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New Drug Application CVT 301 |
New Drug Application CVT 301