The ISSCR Responds to FDA’s Draft Guidance on Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing
On 1 September 2026, the ISSCR submitted comments to the Food and Drug Administration’s (FDA) draft guidance for Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing. ISSCR supports FDA’s desire to share the Agency’s current thinking on the type of prior knowledge (i.e., public and platform knowledge) that may be scientifically appropriate to leverage to advance product development.