Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry; Availability

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 The draft guidance document provides sponsors engaged in the development of human gene therapy (GT) products incorporating ex-vivo and in vivo genome editing (GE) of human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.

Abstract as published in the Federal Register.

The comment window is still open until September 1, 2026. This is the point where industry shapes the final rule — submit comments through the Federal Register document below.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.