RegulatoryGuideline · draft

Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing

🇺🇸 FDA · Wed 03 Jun 2026

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled "Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing." The draft guidance document provides sponsors engaged in the development of human gene therapy (GT) products incorporating ex-vivo and in vivo genome editing (GE) of human somatic cells (GE products) with FDA's recommendations on the type of prior knowledge that may be scientifically appropriate to leverage to advance product development.

Official guideline text: FDA ↗

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Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing

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