05.23.18

Gene Therapies That Could Transform Diseases Get Easier FDA Path

Source: Bloomberg

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 FDA to keep pace with one of biotechnology’s fastest-growing fields, according to a Bloomberg report.

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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