FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | FDA Centennial

Current Good Manufacturing Practice for Combination Products
Practical Issues in Combination Products, May 25, 2006
AdvaMed's Medical Technology Learning Institute

James Cohen
Senior Advisor

Index of Slides 

1. Current Good Manufacturing Practice for Combination Products
2. Overview
3. Challenge
4. OCP Roles
5. OCP Roles, Cont.
6. Postmarket Regulation
7. Postmarket Regulation -- CGMP
8. Draft Guidance
9. Draft Guidance, Cont.
10. Draft Guidance, Cont.
11. Draft Guidance, Cont.
12. Draft Guidance, Cont.
13. Draft Guidance, Cont.
14. Draft Guidance, Cont.
15. Comments on Draft Guidance
16. Comments, Cont.
17. Next Steps
18. Next Steps, Cont.
19. Next Steps, Cont.
20. Next Steps, Cont.
21. Next Steps, Cont.
22. Next Steps, Cont.
23. Postmarket Safety Reporting
24. Postmarket Safety Reporting, Cont.
25. Postmarket Safety Reporting, Cont.
26. Recommendations
27. Recommendations, Cont.
28. OCP Website: http://www.fda.gov/oc/combination/
29. Contact Us -- We’re Here to Help!
30. Conclusion

Return to Format List

Recent OC Presentations Home Page

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility

FDA Website Management Staff