FDA To Ease Review Process For Life-Saving Gene-Editing Therapies: Report
A U.S. regulator reportedly plans to unveil a faster approach to approving custom gene-editing treatments for rare diseases.
Vinay Prasad, who oversees gene therapies in the U.S. Food and Drug Administration, told Bloomberg that regulation needs to evolve as science develops. Prasad reportedly added that scientific advances like Crispr gene-editing technology have forced the agency to relax some of its strict rules.
The agency is“going to be extremely flexible and work very fast with the scientists who want to bring these therapies to kids who need it,” Prasad told Bloomberg.
The executive is reportedly set to publish a paper in early November detailing the FDA's new approach.
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