US FDA’s Confidence In Gene Editing Safety Growing Enough That Regulatory Bar May Be Lowered

Some worries about heritable genetic modifications are subsiding and Center for Biologics Evaluation and Research Director Peter Marks said sponsors should consider the US for regulatory advice and clinical trials in the space.

Peter Marks (third from left) at the NORD Breakthrough Summit
CBER Director Peter Marks (third from left) speaks about gene therapy during the NORD Breakthrough Summit. • Source: National Organization for Rare Disorders (NORD)

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