Gene Editing: Off-Target Effects Should Be A Key Safety Focus During Development, US FDA Says

 
• By Sue Sutter

Clinical development programs for human gene therapy products that incorporate genome editing should address the potential risks of off-target editing as well as unintended consequences of on-target effects, agency says in new draft guidance.

Missed target
Therapeutics incorporating gene editing require special attention to off-target effects. • Source: Alamy

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