NEED HELP ASAP Unit 7 Text Questions
Review Questions

1. What is the purpose of US Government regulation especially as it relates to biotechnology?

2. What prompted the initial concern for regulation in biotechnology and what resulted as an outcome?

3. What are the three federal government regulatory agencies and what areas does each regulate?

4. What are some of the major challenges in today’s biotech regulatory environment?

5. In the latest efforts to modernize the biotech regulatory system, what areas did the national strategy ask federal agencies to focus on and constantly improve?

Critical Thinking Questions

1. What would be the benefits or drawbacks of having one single regulatory agency versus the three separate existing agencies we currently have in place?

2. What is meant by the statement “delicate dance of regulation and innovation”?

3. How does the premarket phase in the regulatory process help companies, and how does it work to the benefit of the consumer?

4. The company 23andMe almost failed because of regulatory issues. What could product developers have done differently?

5. What are the potential benefits of “modernizing” the process of biotech regulation?