The Session Long Project (SLP) assignment is to prepare a case study report of a chemical, biologic, device, or combination noting how the regulatory submission was conducted and interesting aspects of the submission for market authorization. A real chemical, biologic, device, or combination entity developed for human medically therapeutic use should be evaluated. The entity should have been or currently is approved, marketed or both in the United Stated. Further clarification on the regulatory approval and market authorization status is in the requirements for “Analysis” section. Students should consider when searching for a case study candidate that was approved prior to 2000 may have limited information in web-based databases. A Freedom of Information Act (FOIA) request could be completed, but would be quite time consuming.
In general students should write the SLP submission paper like any other research paper. The SLP submission paper should be at least 4-5 pages, but preferably no more than 10 pages. The cover page, table of contents, and a reference list should be included to indicate a logically organized and well-cited paper.
Added on 21.11.2015 14:20
Thank you for all of your help. I have attached the Grading and Writing Rubric Checklist that goes through each section on what exactly needs to be completed. In addition, I have attached two examples that my professor sent to us from last year to use as examples as well. The checklist outlines exactly what needs to be completed. As stated, the drug I chose is Jardiance (empagliflozin).
Please let me know if you have any questions at all. Thank you!
Added on 21.11.2015 14:23
A few tips:
A case study is like a story, but in this case it is about a drug/biologic/device/etc.
Stories should be organized, flowing, and interesting.
Do NOT just report information (i.e., fact after fact and quote after quote) you find in your research. Evaluate, interpret, and analyze the information you present.
Address the relevance and significance of the information you provide in terms of the section and overall case study.v