Analyze an emerging regulatory issue of rwe

Assignment Help Other Subject

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

Questions Cloud

How might dei impact your organization for healthcare access : How might DEI impact your organization for Healthcare access, Workplace non-discrimination, and Youth safety and fair treatment in each state in California.

Examined the association of the nine country averages with : Review the following description and decide if the study can be best categorized as case control, cohort (prospective or retrospective), cross-sectional

What modifications need to be made with the class ii : What modifications need to be made with the Class II restoration procedure as compared to the Class III restoration?

What would you say to the concerned workers involved : What would you say to the concerned workers involved? What action would you take? Provide Controls at the Source, Along the Path and At the Worker Level.

Analyze an emerging regulatory issue of 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

Identify the types of bases or liners : Identify the types of bases or liners that would be used in anterior composites. 3. Describe postoperative instructions for deep restorations.

Private company like facebook and twitter : Should the government, or even a private company like Facebook and Twitter, be able to control what people can and cannot publish?

What are some examples of primary data analysis : What are some examples of Primary data analysis and Secondary data analysis in the healthcare? Please cite some examples.

Established jim crow order in the south : What would have been so frightening for Africa-Americans to publicly demonstrate against the established Jim Crow order in the south?

User Account

All Pages