Levemir Insulin Detemir June 16, 2005 NDA 021536

Levemir Insulin Detemir June 16, 2005 NDA 021536

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.

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Format: In general students should write the SLP submission paper like a standard college 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, headings, and references should be included to indicate a logically organized and well-cited paper