Engineered tissues: The regulatory path from concept to market

Advances in Experimental Medicine and Biology

Volumn 585, Issue , 2006, Pages 363-376

  Hellman, Kiki B ^a  

^a Hellman Group LLC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84934443335     PISSN: 00652598     EISSN: None     Source Type: Book Series    
DOI: 10.1007/978-0-387-34133-0_23     Document Type: Conference Paper

References (10)

1. Kiki B. Hellman, Emma Knight, and Charles N. Durfor, Tissue Engineering: Product Applications and Regulatory Issues, Frontiers in Tissue Engineering, pp. 341-366, 1998.
2. Kiki B. Hellman, Ruth R. Solomon, Claudia Gaffey, Charles N. Durfor, and John G. Bishop, III, Regulatory Considerations, Principles of Tissue Engineering, Second Edition, pp. 915-928 (2000).
3. David S. Smith and Kiki B. Hellman, Regulatory Oversight and Product Development: Charting the Path, Regulatory Page, Tissue Engineering, 9(5), 1057-1058 (2003).
4. Kiki B. Hellman and David S. Smith, The Regulation of Engineered Tissues: Emerging Approaches, The Biomedical Engineering Handbook, Tissue Engineering Section, Fourth Edition (in press).
5. Kiki B. Hellman, Introduction, presentation at Inaugural Engineering Tissue Growth Executive Forum, Seattle, Washington (June 2004).
6. Kiki B. Hellman, and David S. Smith, FDA Regulation of Combination Products: Evolving Initiatives, Genetic Engineering News, 25(10) (May 15, 2005).
7. Kiki B. Hellman and David S. Smith, FDA Final 'Current Good Tissue Practice' Rule, Genetic Engineering News, 25(6) (March 15, 2005).
8. Kiki B. Hellman and David S. Smith, Taking a Look at the FDA's Critical Path Initiative, Genetic Engineering News, 25(2) (January 15, 2005).
9. Kim Norton, Regulation Reimbursement - Efficacy vs. Effectiveness: What Determines Coverage, presentation at Inaugural Engineering Tissue Growth Executive Forum, Seattle, Washington (June 9, 2004).
10. Michael J. Lysaght and A.L. Hazelhurst, Tissue Engineering: The End of the Beginning, Tissue Engineering, 10, 309-321 (2004).