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Regulation of Combination Products:
Progress Report
DIA Webinar (1-19-05)

Index of Text Only Slides

  1. Regulation of Combination Products: Progress Report
  2. What We’ll Cover
  3. Combination Products Are Diverse
  4. Combination Products Are Diverse
  5. Regulatory Approaches Are Diverse
  6. Challenges: Overall Regulation
  7. Challenges: Overall Regulation
  8. The Ultimate Regulatory Challenge
  9. Challenges: Assignment
  10. Challenges: Assignment
  11. Challenges: Assignment
  12. Challenges: Assignment
  13. Challenges: Review
  14. Challenges: Review
  15. Challenges: Review
  16. No Title
  17. Jurisdictional Determinations
  18. How do we do it?
  19. PMOA Proposed Rule: May 7, 2004 Federal Register
  20. PMOA Proposed Rule: May 7, 2004 Federal Register -- continued
  21. PMOA Proposed Rule: May 7, 2004 Federal Register -- continued
  22. PMOA Proposed Rule: May 7, 2004 Federal Register -- continued
  23. PMOA Proposed Rule: May 7, 2004 Federal Register -- continued
  24. PMOA: Three Hypothetical Examples
  25. PMOA Proposed Rule: Selected Stakeholder Comments
  26. OCP Assignments of Combination Products (10/1/03 through 9/30/04)
  27. OCP Classification Decisions (Non-Combination Products (10/1/03 – 9/30/04)
  28. Application User Fee Guidance
  29. No Title
  30. Premarket Review
  31. How do we do it?
  32. How do we do it, more
  33. Intercenter Consultation Requests 10/01/03 through 9/30/04
  34. Resource for Industry and Review Staff
  35. How do we do it?
  36. Common questions from industry and staff
  37. Number of Marketing Applications
  38. Dispute Resolution
  39. Dispute Resolution Guidance, Draft
  40. Postmarket Regulation
  41. How do we do it?
  42. Good Manufacturing Practices Guidance
  43. Good Manufacturing Practice Guidance, cont’d
  44. Good Manufacturing Practice Guidance, cont’d
  45. Good Manufacturing Practice Guidance, cont’d
  46. Postmarket regulation
  47. Safety Reporting: postmarket
  48. Safety Reporting
  49. General Considerations for combination product development
  50. Wrap - Up
  51. What’s Still Left to be Done: A Lot
  52. What’s Still Left to be Done: A Lot
  53. The Future is Bright!
  54. OCP Website: http://www.fda.gov/oc/combination/
  55. Contact Us – Office of Combination Products

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