Leveraging Prior Knowledge – When Do Sponsors Not Have to Recreate the Wheel? Breaking Down FDA’s New Draft Guidance From a Nonclinical and Clinical Perspective June 12, 2026 By Mark A. Tobolowsky —

Leveraging Prior Knowledge – When Do Sponsors Not Have to Recreate the Wheel? Breaking Down FDA’s New Draft Guidance From a Nonclinical and Clinical Perspective June 12, 2026 By Mark A. Tobolowsky — https://www.thefdalawblog.com/2026/06/leveraging-prior-knowledge-when-do-sponsors-not-have-to-recreate-the-wheel-breaking-down-fdas-new-draft-guidance-from-a-nonclinical-and-clinical-perspective/?utm_source=rss&utm_medium=rss&utm_campaign=leveraging-prior-knowledge-when-do-sponsors-not-have-to-recreate-the-wheel-breaking-down-fdas-new-draft-guidance-from-a-nonclinical-and-clinical-perspective On June 2, 2026, FDA (specifically, CBER) issued a new draft guidance titled “Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing” (the “Draft Guidance”). As suggested by the title, the Draft Guidance is primarily intended for sponsors developing gene editing products, either ex vivo or in vivo; however, it explains that some of the recommendations may be applicable to other cell and gene therapy products, including AAV vector-based gene therapy products that do not incorporate gene editing.