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SMEs Requested for FDA draft guidance - Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing

  • 1.  SMEs Requested for FDA draft guidance - Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing

    Posted 2 hours ago

    Dear AAPS Pharmaceutical Quality team,

    AAPS is considering a response to the FDA draft guidance on Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing, for public comment (issued April 2026; comments close 14 July 2026). The guidance is here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-assessment-genome-editing-human-gene-therapy-products-using-next-generation-sequencing, and the Federal Register notice is here: https://www.federalregister.gov/documents/2026/04/15/2026-07285/safety-assessment-of-genome-editing-in-human-gene-therapy-products-using-next-generation-sequencing (Docket FDA-2026-D-1255; comment online at regulations.gov).

    Please review and consider your thoughts to the below questions:

    1. Does PQ community feel AAPS should respond? Yes/No

    2. If yes, who from the PQ team would volunteer their expertise to represent PQ on the Response Team?

    Please let me know by EOB June 18.

    Thank you,

    Joe