FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)
FDA Law Blog: Drug Discovery
DECEMBER 6, 2024
Where vector presence is detected, transgene mRNA and/or protein expression levels should also be measured. Section #3: Human Trials Finally, the guidance provides a quick overview of clinical study recommendations. For cell therapy products, the draft guidance notes that in vivo imaging techniques provide certain advantages.
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