Advisory Committees
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September 23, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Materials
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Topic 1
- Draft Agenda
- Final Agenda (PDF - 18KB)
- Roster
- FDA Day 1 Documents: Humanitarian Use Devices (PDF - 130KB)
- FDA Day 1 Documents: Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and Food and Drug Administration Staff: Humanitarian Device Exemption (HDE) Regulation: Questions and Answers (PDF - 139KB)
- Errata- FDA Briefing Document for BH110018
- Summary Minutes (PDF - 61KB)
- Transcript (PDF - 314KB)
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Topic 2
Persons with disabilities having problems accessing these documents files may call 301-827-0314 for assistance.
- Miltenyi Biotec Advisory Panel Briefing Package (DOCM - 7.5MB)
- FDA Briefing Document (PDF - 380KB)
- CliniMACS User Manual US Edition (PDF - 3.1MB)
- Cell Processing Data Summary for BMT CTN 0303 Clinical Trial (PDF - 71KB)
- Protocol Synopsis – BMT CTM Protocol 0303 (PDF - 117KB)
- Protocol Synopsis – BMT CTM Protocol 0101 (PDF - 124KB)
- Protocol Synopsis – Protocol #1001-34 (PDF - 21KB)
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