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FDA guideline for developing cell and gene therapy products

  • 1.  FDA guideline for developing cell and gene therapy products

    Community Leadership
    Posted 2 hours ago

    New guidance from the FDA for gene and cell therapy CMC. I thought you may find it helpful. 

    Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application; Guidance of Industry

    You can also watch a video here for a high-level overview. 

    CMC Flexibilities for Developing Human Cell and Gene Therapy Products for a BLA



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    Kim Huynh-Ba, MS, PMP, FAAPS
    Pharmalytik LLC, Managing Director
    Temple University, RAQA, Adjunct Professor
    Illinois Institute of Technology, Adjunct Professor
    [email protected]
    Newark DE - USA
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