Draft Guidance: Leveraging Prior Knowledge in the Development of Human GT Products Incorporating GE
Office of Therapeutic Products (OTP) · July 31, 2026
A webinar by the Office of Therapeutic Products (OTP) introduced a draft guidance on leveraging prior knowledge in the development of human gene therapy and genome‑editing products; presenters gave examples for CMC, nonclinical/bioinformatics and clinical data and opened a public comment period that closes 2026-09-01.
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