The FDA released today (2Jun26) this draft guidance: "Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing"
This 23-page draft guidance covers how to use prior knowledge to support chemistry, manufacturing, and controls (CMC); nonclinical; and clinical development of gene therapy products. It also notes that that the information may be useful beyond genome editing therapies:
"While this draft guidance specifically focuses on GE products, some of the recommendations, when finalized, are or may be applicable to other CGT products, such as adeno-associated viral (AAV) vectors, nanoparticle-based GT products, and ex vivo-modified cell-based GTs that do not incorporate GE. However, additional considerations may also apply to these related product types, based on the specific product and manufacturing process, that are beyond those recommended in this guidance."
The release announcement with link to the draft guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/leveraging-prior-knowledge-development-human-gene-therapy-products-incorporating-genome-editing
#FDA #GenomeEditing
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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