References

1. Food and Drug Administration, Health and Human Services. 2002. Cordis presentation: CYPHER™ Sirolimus-eluting Coronary Stent at the FDA Circulatory System Devices Panel on October 22.

2. Patterson, N. 2003. Faster approvals seen for drug/device combination products. BBI Newsletter 26:247-252.

3. Inose, C. and Brown, M. May 2002. CPs in the US: navigating the regulatory jungle. Reg AFF Focus.

4. Garrison C. May 2002. CPs in Europe: a case study. Reg AFF Focus.

5. Mohammed F. 2003. International filing requirements and strategies for combination medical device/drug products. N.O.C. (newsletter of the Canadian Association of Professional Regulatory Affairs). 58:15-17.

6. Food and Drug Administration, Health and Human Services. 2002. Quality System Regulation. 21 CFR §820.

7. Food and Drug Administration, Health and Human Services. 2002. Current Good Manufacturing Practice for Finished Pharmaceuticals. 21 CFR §211.

8. Food and Drug Administration, Health and Human Services. 2002. Orphan Drugs. 21 CFR §316.

9. Food and Drug Administration, Health and Human Services. 2002. Humanitarian Use Devices. 21 CFR §814(H).

10. Food and Drug Administration, Health and Human Services. 2002. Product jurisdiction. 21 CFR §3.

11. Food and Drug Administration, Health and Human Services. 1991. Intercenter Agreement Between The Center for Drug Evaluation and Research and The Center for Devices and Radiological Health.

12. Byrd, G. N. CPs and regulatory strategy. November 1997. Reg AFF Focus.

13. Leichter, L. February 2001. Medical device combination products. Reg AFF Focus.

14. Food and Drug Administration, Health and Human Services. 1995. Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices (G95-1).

15. International Organization for Standardization. 1992-2003. ISO 10993 Biological Evaluation of Medical Devices, parts 1 to 17.

16. Food and Drug Administration, Health and Human Services. 2002. Guidance for Industry and Reviewers (Draft), Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers.

17. Babapulle, M. N. and Eisenberg, M. J. 2002. Coated stents for the prevention of restenosis: part 1. Circulation 106:2734-2740.

18. Teirstein, P. S. Living the dream of no restenosis. 2001. Circulation 104:1996-1998.

19. Virmani, R., Kolodgie, F. D., Farb, A., and Lafont, A. 2003. Drug-eluting stents: are human and animal studies comparable? Heart 89:133-138.

20. Weekley, L. B., Guittin, P., and Chamberland, G. 2002. The International Symposium on Regulatory Testing and Animal Welfare: recommendations on best scientific practices for safety evaluation using nonrodent species. ILAR J. 43:S118-S122.

21. Schwartz, R. S. and Edelman, E. R. 2002. Drug-eluting stents in preclinical studies: recommended evaluation from a consensus group. Circulation. 106:1867-1873.

22. Food and Drug Administration, Health and Human Services. 2002. Best Practices to Get an IDE Approved for a Drug-Eluting Coronary Stent. Presented at the FDA Questions and Answers session, Cardiovascular Radiation Therapy 6th Annual Meeting.

23. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 2000. ICH M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals.

24. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 2000. ICH S7A, Safety Pharmacology Studies for Human Pharmaceuticals.

25. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 2002. ICH S7B, Safety Pharmacology Studies for Assessing the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) By Human Pharmaceuticals.

26. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 1995. ICH S2A, Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals.

27. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 2002. ICH S2B, Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals.

28. Teirstein, P. S., Massullo V., Jani S., et al. 1997. Catheter-based radiotherapy to inhibit restenosis after coronary stenting. N. Engl. J. Med. 336:1697-1703.

29. Chamberland G. July 30, 2003. Navigating US and international pathways for products with no approved component. Presentation given at the CPs conference, hosted by Barnett International.

30. Gobeil, J. F., Leclerc, G., Martel, R. et al. October 20-24, 2001. Pharmacokinetics of a stent-based local drug delivery of a short DNA oligonucleotide coupled with P32 (Oliglow) in a swine model. Canadian Cardiovascular Congress, Halifax, Nova Scotia (Abstract).

31. Food and Drug Administration, Health and Human Services. 1981. Guidelines for the Clinical Evaluation of Radiopharmaceutical Drugs.

32. The European Agency for the Evaluation of Medicinal Products. 1991. Guideline on Radiopharmaceuticals.

33. The Council of European Communities. 1989. Council Directive 89/343/EEC.

34. Holder L. September 1999. Clinical trials of medical devices containing radioactive isotopes. Reg AFF Focus.

35. Food and Drug Administration, Health and Human Services. 1995. Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices: Intravascular Stents.

36. van der Giessen, W. J., Lincoff, A. M., Schwartz R.S., et al. 1996. Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries. Circulation. 94:1690-1697.

37. Campbell, R. and Edelman, E. R. 1995. Endovascular stent design dictates experimental restenosis and thrombosis. Circulation. 91:2995-3001.

38. European Commission. 2000. Guide to the Implementation of Directives Based on the New Approach and the Global Approach. European Communities.

39. Dieners, P. July 2000. Recent developments in European regulatory affairs. Reg AFF Focus.

40. Williams, M. H. January 1999. An overview of the European Union and how it functions. Reg AFF Focus.

41. The Council of European Communities. 2001. Council Directive 2001/83/EEC as amended.

42. The Council of European Communities. 1993. Council Directive 93/42/EEC as amended.

43. The Council of European Communities. 1990. Council Directive 90/385/EEC as amended.

44. Brooks P. and Johnston M. November 2001. Medical device manufacturers and their notified body: how to make the partnership a success. Reg AFF Focus.

45. European Commission. 2001. Designation and Monitoring of Notified Bodies within the Framework of EC Directives on Medical Devices (MEDDEV 2.10-2 Rev 1).

46. Ruston, R. March 1999. The European legislative scene for devices. Reg AFF Focus.

47. Medical Devices Experts Group. 2002. Report on the Functioning of The Medical Devices Directive.

48. European Commission. 1994. Guidelines Relating to the Application of the Council Directive 90/385/EEC on Active Implantable Medical Devices and the Council Directive 93/42/EEC on Medical Devices (MEDDEV 2.1/1).

49. European Commission. 2001. Guidelines for the Classification of Medical Devices (MEDDEV 2.4/1 Rev. 8).

50. Medicines and Healthcare Products Regulatory Agency. 2003. MHRA Guidance Note No. 8. A Guide to What is a Medicinal Product.

51. European Commission. 2001. Guidelines Relating to the Application of the Council Directive 90/385/EEC on Active Implantable Medical Devices and the Council Directive 93/42/EEC on Medical Devices (MEDDEV 2.1/3 rev. 2).

52. Medicines and Healthcare Products Regulatory Agency. 2003. MHRA Guidance Note No. 18. Guidance for Notified Bodies: Devices Which Incorporate a Medicinal Substance.

53. Stabin, M. G. 1996. MIRDOSE: A personal computer software for internal dose assessment in nuclear medicine. J. Nucl. Med. 37:538-546.

54. Janicki, C., Duggan, D. M., Coffey, C. W., et al. 1997. Radiation dose from a phosphorus-32 impregnated wire mesh vascular stent. Med. Phys. 24:437-445.

55. Health Canada. 1999. Drug and Medical Device CP Decisions.

56. Therapeutic Products Programme, Health Canada. 1999. Drug/Medical Device Combination Products.

57. Food and Drug Administration, Health and Human Services. 1997. Design Control Guidance for Medical Device Manufacturers.

58. Food and Drug Administration, Health and Human Services. 2002. Good Laboratory Practice for Nonclinical Laboratory Studies. 21 CFR §58.

59. Schievink, W. I. 1997. Intracranial Aneurysms. N. Engl. J. Med. 336:28-40.

60. Raymond, J, Leblanc, P., Desfaits, A. C. 2002. In situ beta radiation to prevent recanalization after coil embolization of cerebral aneurysms. Stroke. 33:421-427.

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