Regulatory considerations for novel gene therapy products: a review of the process leading to the first clinical lentiviral vector.

@article{Manilla2005RegulatoryCF,
  title={Regulatory considerations for novel gene therapy products: a review of the process leading to the first clinical lentiviral vector.},
  author={Peter Manilla and Tessio Rebello and Cathleen Afable and Xiaobin V Lu and Vladimir Slepushkin and Laurent M P F Humeau and Kathy Schonely and Yajin Ni and Gwendolyn K. Binder and Bruce L Levine and R G Macgregor and Carl H June and Boro Dropuli{\'c}},
  journal={Human gene therapy},
  year={2005},
  volume={16 1},
  pages={17-25}
}
This review is intended to exemplify the roles and responsibilities of the two agencies under the Department of Health and Human Services, the National Institutes of Health and the Food and Drug Administration, that have oversight for human gene transfer clinical protocols, as seen through our experience of bringing a first-in-its-class lentiviral vector to clinical trials. In response to the changing circumstances in gene therapy research between 1999 and 2002, the concerns of these agencies… CONTINUE READING

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