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A Regulatory Risk-Based Approach to ATMP/CGT Development: Integrating Scientific Challenges With Current Regulatory

Laura I Salazar-Fontana1,2,3

  • 1LAIZ Regulatory Science Consulting, Lausanne, Switzerland.

Frontiers in Medicine
|June 1, 2022
PubMed

Keywords:
EMAFDAadvanced therapy medicinal productscell and gene therapy productscell therapygene therapyregulatory riskregulatory science

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