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USFDA Guidance: Leveraging Prior Knowledge in Genome Editing Gene Therapy Development
As genome editing technologies continue to advance, sponsors are increasingly developing innovative gene therapies targeting rare, serious, and life-threatening diseases. These programs often involve complex manufacturing processes, extensive nonclinical studies, sophisticated analytical testing, and lengthy clinical development timelines. To support more efficient development pathways, the FDA released the draft guidance, Leveraging Prior Knowledge in the Development of Huma
Sharan Murugan
24 hours ago3 min read