Comparing Title 45 and Title 21
Overview
Take a guided overview of the FDA–Title 21 and HHS–Title 45 regulations that govern research studies.
Learning Objectives
- Discuss the role of the FDA and the HHS in research studies
- Explain the importance of regulations and compliance for research studies
- Describe the differences between FDA Title 21 and HHS Title 45
- Determine whether Title 21, Title 45, or both apply to several example scenarios
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