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Fundamental Elements in Gene Vector Development The information provided below is intended to aid investigators in understanding common elements in the development of gene therapy vectors from preclinical testing to clin
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Document Date: 2014-03-13 11:56:15


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File Size: 188,37 KB

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Company

Use Committee IBC / /

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Facility

FDA’s Center / /

IndustryTerm

manufacturing / gene therapy product / intended clinical product / manufacturing information / /

MedicalCondition

Target disease / /

MedicalTreatment

gene therapy / /

Organization

FDA United States Food and Drug Administration GMP Good Manufacturing Practices IACUC Institutional Animal Care and Use Committee IBC Institutional Biosafety Committee IRB OBA P/T RAC DSMB Institutional Review Board office of Biotechnology Activities Pharmacology/ Toxicology Recombinant DNA Advisory Committee Data / FDA / National Institute of Health / Biotechnology Activities Pharmacology/ Toxicology Recombinant DNA Advisory Committee Data and Safety Monitoring Board / office of Cellular / /

Person

RAC DSMB / Patrick Riggins / Gene Therapies / /

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Position

Investigator / Branch Chief / /

ProvinceOrState

Indiana / /

Technology

gene therapy / Regulatory Activities Finalize Clinical Protocol / IACUC approval Perform toxicology testing Draft Clinical Protocol / Recombinant DNA / Biotechnology / pdf / /

URL

http /

SocialTag