FDA Logo links to FDA home page Skip Navigation
U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website
horizonal rule
Dockets Management

Back


2005D-0310
BKG 1
Volume 2

Reference List

Reference 1 - FDA Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors, October 2000 (http://www.fda.gov/cber/gdlns/retrogt1000.pdf).

Reference 2 - Donahue, R.E., et al. Helper virus induced T cell lymphoma in nonhuman primates after retroviral mediated gene transfer. Journal of Experimental Medicine 1992; 176: 1125-1135. Published Material

Reference 3 - Nyberg, K., et al. Workshop on long-term follow-up of participants in human gene transfer research. Molecular Therapy 2004; 10(6): 976-980. Published Material

Reference 4 - FDA Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Thelrapy, March 1998 (http://www.fda.gov/cber/gdlns/somgene.pdf).

Reference 5 - Bauer, S., Current FDA approach for preclinical vector biodistribution studies. March 12, 1999: Recombinant DNA Advisory Committee Meeting (http://wvwv4.od.nih.gov/oba/rac/minutes/3-99RAC.htm#IX).

Reference 6 - Shayakhmetov, D.M., et al. A high-capacity, capsid-modified hybrid adenovirus/adeno-associated virus vector for stable transduction of human hematopoietic cells. Journal of Virology 2002; 76(3): 1135-1143. Published Material

Reference 7 - Goncalves, M.A., et al. Stable transduction of large DNA by high-capacity adeno-associated virus/adenovirus hybrid vectors. Virology 2004; 321(2): 287-96. Published Material

Reference 8 - Picard-Maureau, M., et al. Foamy virus-adenovirus hybrid vectors. Gene Therapy 2004; 11(8): 722-8. Published Material

Reference 9 - Yam, S.R.., et al., Transposition from a gutless adeno-transposon vector stabilizes transgene expression in vivo. Nature Biotechnology 2002; 20(10): 999-1005. Published Material

Reference 10 - Wang, Z., et al., Detection of integretation of plasmid DNA into host genomic DNA following intramuscular injection and electroporation. Gene Therapy 2004; 11(8): 711-21. Published Material

Reference 11 - Modlich, U., et al., Leukemias following retroviral transfer of multidrug resistance 1 (MDR1) are driven by combinatorial insertional mutagenesis. Blood. 2005; 1-38. Published Material

Reference 12 - Hacein-Bey-Abina, S., et al. LMO2-associated clonal T cell proliferation in two patients after gene therapy for SCID-Xl. Science 2003; 302(5644): 415-9. Published Material

Reference 13 - Couzin, J., Kaiser, J. As Gelsinger Case Ends, Gene Therapy Suffers Another
Blow. Science 2005; 307: 1028 Published Material


Top | Back

Page last updated August 30, 2005 RSChorizonal rule
Dockets Home Page | Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

FDA/Dockets Management