Principal Brent Morse, M.S. and Senior Principal and Head of Nonclinical Nathan Manley, Ph.D. published today on the topic of "FDA's Updated Guidance On Human Genome Editing: New Implications & Remaining Questions" via Life Science Connect's cellandgene.com.
"In March 2022, the U.S. FDA released the draft guidance for industry Human Gene Therapy Products Incorporating Human Genome Editing. The purpose of this draft document was to share preliminary FDA thoughts about proper implementation and control of human genome editing (GE) in therapeutic product development and to invite commentary from the scientific community about potential improvements to the guidance. Numerous scientific organizations and interested parties, including the American Society for Cell and Gene Therapy and the International Society for Cell Therapy, among others, provided feedback to the FDA about how to improve the clarity and utility of the guidance. On Jan. 29, 2024, the FDA released the final version1 of the guidance document."
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