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Society of Toxicologic Pathology Annual Meeting - June 20, 2005

Patricia Y. Love, MD, MBA, Assoc. Director OCP

Index of Slides

  1. Society of Toxicologic Pathology Annual Meeting - June 20, 2005
  2. What Are Combination Products?
  3. Office of Combination Products*
  4. Critical Regulatory Challenge
  5. Topics: Activities & Approaches
  6. Classification and Assignment Section
  7. Classification and Assignment
  8. Assignment Determination Process
  9. Formal Assignment
  10. OCP Formal Classification & Assignments*: 10/1/03 – 9/30/04
  11. Challenge
  12. PMOA Proposed Rule: May 7, 2004 Federal Register
  13. PMOA Proposed Rule: May 7, 2004 Federal Register, cont’d
  14. PMOA Proposed Rule: May 7, 2004 Federal Register, cont’d
  15. PMOA Proposed Rule: May 7, 2004 Federal Register, cont’d
  16. PMOA Proposed Rule: May 7, 2004 Federal Register, cont’d
  17. PMOA Proposed Rule: May 7, 2004 Federal Register; cont’d
  18. Challenges: Assignment
  19. PMOA and preclinical PD studies?
  20. PMOA and preclinical PD studies, cont’d?
  21. Once Assigned then What?
  22. Different Regulatory Environments
  23. Once assigned, then what … cont’d?
  24. Premarket Review Section
  25. Premarket Review
  26. Review Process
  27. What if you disagree or there is a glitch in the process?
  28. Combination Product Dispute Resolution Guidance, Final 2005
  29. Limited activity
  30. Practical pre-clinical considerations
  31. Practical pre-clinical considerations, cont’d
  32. Practical pre-clinical considerations, cont’d
  33. Practical pre-clinical considerations, cont’d
  34. Postmarket Regulation Section
  35. Postmarket regulatory challenges
  36. Good Manufacturing Practice Guidance; Draft September 29, 2004
  37. Good Manufacturing Practice Guidance; Draft, Cont’d
  38. Good Manufacturing Practice Guidance; Draft, Cont’d
  39. Good Manufacturing Practice Guidance; Draft, Cont’d
  40. Ongoing activity: Safety Reporting - Postmarket
  41. Pre and Post Market Considerations
  42. Number of Marketing Applications
  43. Application User Fee Guidance; Final April 2005
  44. Innovative combination products: barrier to innovation waiver, cont’d
  45. Other Ongoing Activities Section
  46. Ongoing activity: Mutually Conforming Labeling
  47. More to do?
  48. Recommendations
  49. To Contact Us

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