Please make sure to tie back to product development in some capacity.
Description: This paper will be a thorough legal, regulatory and business analysis of an emerging issue[a current topic of dispute, controversy, or complexity that is ripe for Congress, FDA or industry (or some combination thereof) to resolve] in the FDA-regulated therapeutic product marketplace. This final paper will analyze an emerging regulatory issue of your choice in the therapeutic product development area and explain the legal, policy, and business implications of the issue, including but not limited to: Issue: Identify the emerging issue and policy concern(s) and explain the reason that this issue is a current challenge. Rule: what are the current statutes, regulations or guidance documents applicable to this emerging issue. Analysis: what is the appropriate resolution of this emerging issue, what are the pros and cons of a course of action (COA), who are the stakeholders involved and how would you balance their respective interests; Conclusion: make a final recommendation(s) to resolve the issue in the future, detailing what action should be taken by whom. Expectations: This paper must be 10 pages, double-spaced, not including the title, references and any appropriate appendices. Additional information about the final paper, including the required “IRAC –Issue, Rule, Analysis, Conclusion” formcixat will be posted to Blackboard.
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