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Louis Cicchini, PhD, and Michael Day, PhD

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Articles by Louis Cicchini, PhD, and Michael Day, PhD

How Cell and Gene Therapy Developers Can Reduce Risk of FDA Complete Response Letters With Proactive CMC Strategies

ByLouis Cicchini, PhD, and Michael Day, PhD
October 1st 2025

How cell and gene therapy developers can lessen the chances of receiving FDA complete response letters through the use of proactive chemistry, manufacturing, and controls strategies.

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  • How Cell and Gene Therapy Developers Can Reduce Risk of FDA Complete Response Letters With Proactive CMC Strategies
    How Cell and Gene Therapy Developers Can Reduce Risk of FDA Complete Response Letters With Proactive CMC Strategies

    October 1st 2025



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