Non-clinical testing for inadvertent germline transmission of gene transfer vectors

This document provides guidance on non-clinical inadvertent germline transmission testing needed to support clinical development of gene transfer medicinal products consisting of or containing replication-incompetent vectors, genetically modified viruses or so-called naked nucleic acids directly administered to humans.

Keywords: Non-clinical, inadvertent germline transmission, gene transfer vector, genetically modified viruses, adeno-associated viral (AAV)

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