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Dockets Management

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Food and Drug Administration

Pediatric Advisory Committee

December 9, 2008

BRIEFING INFORMATION

 Protocol Documents

2008-04406b1-01 (ASCT0631 Protocol (pdf)
2008-04406b1-02 (Correspondence from the COG CIRB (pdf)

Parental Permission and Child Assent Documents

2008-04406b1-03 (ASCT0631 Parental Permission Recipient (pdf)
2008-04406b1-04 (ASCT0631 Parental Permission Sibling Donor (pdf)
2008-04406b1-05 (ASCT0631 Donor Assent 7-11yo (pdf)
2008-04406b1-06 (ASCT0631 Donor Assent 12-17yo (pdf)
2008-04406b1-07 (ASCT0631 Recipient Assent 7-11yo (pdf)
2008-04406b1-08 (ASCT0631 Recipient Assent 12-17yo (pdf)

IRB Review Documents

2008-04406b1-09 (IRB Minutes July 2 2008 (pdf)
2008-04406b1-10 (Stipulation Rebuttal Letter ASCT0631 (pdf)
2008-04406b1-11 (IRB Minutes September 3, 2008 (pdf)
2008-04406b1-12 (ASCT0631 - 407-55 Cover Letter Final October 1, 2008 (pdf)

DOCUMENTS SUBMITTED BY SPONSOR (NCI)

2008-04406b1-13 (ASCT0631 Cover Letter NIH 11-18-2008 (pdf)
2008-04406b1-14 (ASCT0631 Initial Review APM Letter (pdf)
2008-04406b1-15 (ASCT0631 risk benefit appendix (pdf)
2008-04406b1-16 (BIOETHICS consult jan 2006 G-CSF Study (pdf)

2008-04406b1-17 (OHRP Response re Sibling Benefit 01-2006 (pdf)

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Page last updated November 24, 2008 kkhorizonal rule
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