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BioWest Regulation of Combination Products
November 9, 2005

Mark Kramer

Index of Slides

1. Regulation of Combination Products BioWest 2005
2. What is a Combination Product?
3. Challenge
4. Office of Combination Products
5. Assignment of Combination Products
6. Final PMOA Rule: Definitions
7. Final PMOA Rule: Assignment Algorithm
8. Guidance Document: How to Write a Request for Designation
9. Guidance Document: How to Write a Request for Designation (continued)
10. Cross Labeling
11. Cross Labeling
12. In Progress: Cross Labeling
13. Request for Comments: Number of Marketing Applications
14. Request for Comments: Number of Marketing Applications
15. Draft Good Manufacturing Practice Guidance
16. Good Manufacturing Practice Guidance
17. Request for Comments: Adverse Event Reporting
18. Request for Comments: Adverse Event Reporting
19. Guidance on Application User Fees
20. Guidance on Dispute Resolution
21. OCP Website: http://www.fda.gov/oc/combination/
22. Contact Us -- We’re Here to Help!

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