Unlike traditional drugs, gene therapies are intended to be given once, transform the inner workings of the body and last for a lifetime.
By Michelle Cortez|May 28, 2018 at 10:47 AM
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New therapies that may cure diseases caused by defective genes will get a faster path to approval by U.S. regulators, part of an effort by the Food and Drug Administration to keep pace with one of biotechnology’s fastest-growing fields.
Unlike traditional drugs, gene therapies are intended to be given once, transform the inner workings of the body and last for a lifetime. For regulators, the challenge is to find ways to get the new therapies to desperate patients while balancing the need to monitor their long-term safety for years after approval, FDA Commissioner Scott Gottlieb said Tuesday.
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