Gene Editing: The Regulatory Perspective

Sarfaraz K. Niazi

doi:10.20944/preprints202307.2062.v1

Preprint Review Version 1 Preserved in Portico This version is not peer-reviewed

Version 1 : Received: 28 July 2023 / Approved: 28 July 2023 / Online: 31 July 2023 (04:55:07 CEST)

Gene or genome editing (GE) revises, removes, or replaces a mutated gene at the DNA level; it is a tool. Gene therapy (GT) offsets mutations by introducing a "normal" version of the gene into the body while the diseased gene remains in the genome; it is a medicine. So far, no GE product has been approved, as opposed to 22 GT products that cost up to millions of dollars per dose. The FDA has recently added a guideline specific to gene editing that should be understood to enable faster development of GE products; at the same time, the FDA also needs to bring more clarification and make several amendments to this guideline to make it more rational.

gene editing; gene therapy; FDA; regulatory approval

Medicine and Pharmacology, Clinical Medicine

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Gene Editing: The Regulatory Perspective

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