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Regulation of Combination Products: ACRP 2006

Mark Kramer, April 30, 2006

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1. Regulation of Combination Products: ACRP 2006
2. Overview
3. What is a Combination Product?
4. Combination Products Are Diverse
5. Challenge
6. Office of Combination Products
7. OCP Roles
8. OCP Objectives
9. Assignment of Combination Products
10. Section 503(g) of the Act
11. Final Rule: August 25, 2005 Federal Register
12. Final PMOA Rule: Definitions
13. Final PMOA Rule: Constituent Parts
14. Final PMOA Rule: Assignment Algorithm
15. Final Rule: Contents of Request for Designation
16. Request for Designation (RFD) – General Information
17. When Should an RFD be Submitted?
18. Guidance Document: How to Write a Request for Designation
19. Guidance Document: How to Write a Request for Designation
20. Jurisdictional Update: Intercenter Agreements www.fda.gov/oc/combination
21. Jurisdictional Update: Intercenter Agreements www.fda.gov/oc/combination
22. Premarket Review
23. Resource for Industry and Review Staff
24. How do we do it?
25. Intercenter Consultation Requests 10/01/04 through 9/30/05
26. Numbers and Types of Combination Products - FY 2005
27. Proposed Rulemaking
28. Draft Good Manufacturing Practice Guidance
29. Request for Comments: Adverse Event Reporting
30. Request for Comments: Adverse Event Reporting
31. Request for Comments: Number of Marketing Applications
32. Request for Comments: Number of Marketing Applications
33. Cross Labeling
34. Cross Labeling Workshop
35. Critical Path Issues for Combination Products
36. Recommendations
37. OCP Website: http://www.fda.gov/oc/combination/
38. Contact Us -- We’re Here to Help!

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