How to navigate gene editing regulatory hurdles: FDA webinar clarifies newly finalized guidance

Lexology March 14, 2024
Hogan Lovells

Gene editing (GE) therapies hold immense promise for treating a myriad of diseases. Like most novel products, their development and regulatory approval necessitate careful consideration of critical factors. FDA officials recently held a webinar following publication of a final version of a 2022 draft guidance, “Human Gene Therapy Products Incorporating Human Genome Editing.” The webinar included a discussion of recommendations in the development of gene editing therapies, including considerations for the Chemistry, Manufacturing, and Controls (CMC), nonclinical, and clinical portions of a development program. Each are discussed below.

CMC considerations

Changes from the draft guidance:

In January 2024, FDA published the final guidance “Human Gene Therapy Products Incorporating Human Genome Editing,” finalizing a March 2022 draft guidance of the same...

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