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Open Peer Commentaries

Clinically Driven Safety Benchmarks

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Pages 22-23 | Published online: 18 Apr 2012

REFERENCES

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  • Food and Drug Administration, Center for Biologics Evaluation and Research . 2003 . Guidance for reviewers. Instruction and template for chemistry, manufacturing, and control (CMC) reviewers of human somatic cell therapy investigational new drug applications (INDs) . Available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/03d0349gdl.pdf (accessed January 10, 2010)
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