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Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Agency IQ

APRIL 12, 2024

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue.

Production

Production FDA Therapies Biochemical Assays

Gene editing extends lifespan in mouse model of prion disease

Broad Institute

JANUARY 14, 2025

When I received my genetic test report in 2011, the world had never heard of base editing. His lab had just developed base editing, a gene-editing approach that makes single-letter changes in DNA and can shut down protein production using strategies including installing a stop signal in the genetic code.

Disease

Disease DNA Protein Production Treatment

Drug Discovery Digest

Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Gene editing extends lifespan in mouse model of prion disease

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