Module 3: Market Access Process
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Lessons
1. Market Access Through Regulations
2. Regulations Versus Statutes
3. Basic Requirements of the U.S. Regulatory System
4. How the Process Works
5. Considerations During the Process
6. Updating Existing Market Access Requirements
7. Module Conclusion
Topics
1. Receive Request for Market Access
2. Prepare Risk Analysis
3. Prepare Other Required Analyses
4. Prepare a Proposed Rule or Notice
5. Undergo Legal and Policy Review
6. Publish in the
Federal Register
7. Address Comments
8. Publish a Final Rule or Notice
9. Implement Requirements
10. Lesson Assessment
11. Lesson Summary
Resources
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Glossary
Documents
Acknowledgements
Lesson 4: How the Process Works
Topic 11: Lesson Summary
course_01/lesson_04/topic_11/asset_001
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