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.
- Discuss about an issue concerning a current social issue or modern technology and write an essay in which you take a position on that issue.
- Identify the three essential elements to management, maintaining a balance between the current culture, and improving relationships to minimize resistance to change.
- Explain how the Act of God doctrine, can be used to eliminate liability in contracts for failure to perform.
- What experiences have you had working with children with psychological difficulties?
- Identify measures to assist the individual to achieve the tasks of his/her stage of development.
- Discuss and analyse the Trifler letters to the serialized articles on natural philosophy and history.
- Do you agree with the concept that individuals self-medicate in relation to stress, coping, and substance-related and addictive disorders?
- Discuss nation-states in the world today, and different types of political institutions are spread among them.
- Summarize, analyze, and discuss some of the key aspects of that Compliance Program Manual, and how some of those key aspects relate to promoting product safety and efficacy.
- Explain how to reduce the use of excessive police force that especially targets communities of color in the United States.