FDA Clears Way For Faster Personalized Gene Editing Therapy

A top United States regulator plans to unveil a faster approach to approving custom gene-editing treatments, a move designed to unleash a wave of industry investment that will yield cures for patients with rare diseases. From a report: Vinay Prasad, who oversees gene therapies at the Food and Drug Administration, said scientific advances, like Crispr, have forced the agency to relax some of its strict rules. As an example, he cited the case of 10-month-old KJ Muldoon, who this year became the first person in history to have his genes custom edited to cure an inherited disease. "Regulation has to evolve as fast as science evolves," Prasad said in an interview with Bloomberg News. 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 plans to publish a paper in early November outlining the FDA's new approach. He predicted it will spark interest in developing treatments for conditions that may affect only a handful of people.

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