A comprehensive analysis of CBER experience with AAV gene therapy IND submissions
Summary
Nature Biotechnology, Published online: 12 November 2026; doi:10.1038/s41587-026-03378-9 An analysis of Investigational New Drug (IND) submissions to the US Food and Drug Administration (FDA) from 1995 to 2025 reveals a rapid growth in adeno-associated virus (AAV) development over three decades and highlights common reasons for regulatory holds that should be considered for successful product development.
Description from Nature.
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A comprehensive analysis of CBER experience with AAV gene therapy IND submissions
Nature Biotechnology, Published online: 12 November 2026; doi:10.1038/s41587-026-03378-9 An analysis of Investigational New Drug (IND) submissions to the US Food and Drug Administration (FDA) from 1995 to 2025 reveals a rapid growth in adeno-associated virus (AAV) development...
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