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Regulation of Biologics and Biotechnology Products in the United States and Europe

Susan O'Shea

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1. Regulation of Biologics and Biotechnology Products in the United States and Europe University of Rhode Island College of Pharmacy Jurisdictional Issues within FDA: Who Decides?
2. Jurisdictional Issues
3. Who does what?
4. If the question is…
5. Option 1: Tissue Reference Group
6. Tissue Reference Group
7. Tissue Reference Group
8. What happens if I disagree with TRG?
9. Office of Combination Products
10. OCP’s Missions
11. Where is OCP?
12. What process does OCP use?
13. RFD Guidance Document
14. RFD Guidance Document
15. How does OCP decide?
16. What if I disagree with OCP’s conclusion in an RFD?
17. If the question is…
18. In general, CBER kept
19. Biological Products Transferred to CDER
20. If there’s still a question
21. What about Combination Products?
22. Primary Mode of Action
23. PMOA
24. PMOA Algorithm
25. PMOA
26. RFD Guidance Document
27. The Bottom Line
28. No Title

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