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Practical Issues in Combination Products
Primary Mode of Action & Request for Designation
AdvaMed MTL Conference -- May 25, 2006

Suzanne O’Shea

Index of Slides

1. Practical Issues in Combination Products Primary Mode of Action & Request for Designation AdvaMed MTL Conference May 25, 2006
2. In the beginning…
3. Office of Combination Products
4. OCP’s Roles:
5. OCP Objectives
6. In a nutshell
7. Where is OCP?
8. I am a combination product
9. Primary Mode of Action
10. PMOA continued
11. Mode of Action
12. Primary Mode of Action
13. PMOA algorithm
14. PMOA CDER or CDRH?
15. More PMOA examples
16. More PMOA examples
17. The last PMOA example
18. Request for Designation (RFD)
19. Who should file an RFD?
20. What happens if I don’t file an RFD?
21. When should I file an RFD?
22. RFD Content
23. Guidance Document
24. Guidance Document
25. RFD Processing
26. RFD processing
27. What if I disagree with RFD decision?
28. What’s the effect of an RFD letter?
29. RFD Statistics
30. How to find out…
31. Intercenter Agreements
32. Intercenter Agreements
33. Jurisdictional Determinations
34. Jurisdictional Updates
35. RFD letters
36. Examples of Approved Combination Products
37. Chemical Action
38. Perhaps the easiest way to find out…
39. Contact Us!
40. Contact Us!
41. No Title

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