Analyze an emerging regulatory issue of rwe

Reference no: EM133431629

One emerging issue in therapeutic product development is the use of real-world evidence (RWE) in regulatory decision-making. thorough legal, regulatory and business analysis of an emerging issue. with the use of real-world evidence (RWE), Kindly answer the following-

Why is it an 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 related to RWE.
Analyze an emerging regulatory issue of RWE in the therapeutic product development area and explain the legal, policy, and business implications of the issue, including but not limited to:
What is RWE Issue: Identify the RWE 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 RWE current issue.
Analysis: what is the appropriate resolution of this emerging RWE issue,
What are the pros and cons of a course of action (COA),
Who are the stakeholders involved (in details) and how would you balance their respective
interests.
Conclusion: Make a final recommendation(s) to resolve the RWE issue in the future, detailing what action
should be taken by whom.

Reference no: EM133431629

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