Propose a topic and write a 7 page paper on a current topic of dispute, controversy, or complexity that is ripe for Congress, FDA or pharmaceutical industry. This paper will analyze an emerging regulatory issue of the group’s choice 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 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.