By Michelle Fay Cortez Published 2:30 pm, Tuesday, May 22, 2018 New therapies that may cure diseases caused by defective genes will get a faster path to approval by federal 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. “For some of these products, there’s going to be some uncertainty, even at the time of approval,” Gottlieb said in a speech at the Alliance for Regenerative Medicine’s annual board meeting. “But these products are initially being aimed at devastating diseases, many of which are fatal and lack available therapy. In these settings, we’ve traditionally been willing to accept more uncertainty to facilitate timely access to promising therapies.” The agency plans to focus first on hemophilia, an inherited condition where the body is unable to form blood clots because it doesn’t produce a… Read full this story
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