Regulatory frameworks for cell and tissue based therapies in Europe and the USA

Regenerative Medicine: From Protocol to Patient

Volumn , Issue , 2011, Pages 937-968

  Tiedemann, Gudrun ^a   Sethe, Sebastian ^b  

^a UNIVERSITY OF ROSTOCK   (Germany)

^b DURHAM UNIVERSITY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84911914304     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1007/978-90-481-9075-1_39     Document Type: Chapter

References (11)

1. http://ec.europa.eu/enterprise/newapproach/nando/.
2. http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm123224.htm.
3. Beginning with the "Reinventing the Regulation of Human Tissue" discussion paper CBER February 1997.
4. "Definition of Primary Mode of Action of a Combination Product" Fed Regist. 2005 Aug 25;70(164):49848-62.
5. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/TissueEstablishmentRegistration/FindaTissueEstablishment/ucm110270.htm.
6. CTGTAC Meeting #45, April 10, 2008 Briefing: "Cellular Therapies Derived from Human Embryonic Stem Cells - Considerations for Pre-Clinical Safety Testing and Patient Monitoring".
7. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122886.htm.
8. FDA Draft Guidance for Industry: INDs-Approaches to Complying with cGMP During Phase 1.
9. Pharmaceutical Inspection Co-operation Scheme. Recommendation on sterility testing, Pharmaceutical inspection convention (1 November 2002) PI 012-1.
10. Cobe et al. "Microbiological contamination in stem cell cultures" in: Cell Biology International; Vol.31, Sept. 2007, pp. 991-995.
11. FDA Guidance for Industry - cGMP for Phase 1 Investigational Drugs; July 2008.