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Experts Criticize FDA's Plan To Regulate Genomic Tests

Legal, ethics and genomic scholars took to the New England Journal of Medicine to criticize FDA's plan to regulate laboratory-developed tests.

A group of legal, ethics and genomics experts have attacked FDA's plans to regulate genomic tests as part of the agency's proposed laboratory developed tests (LDT) paradigm. They argue the agency lacks the statutory authority and resources to regulate the tests, and could stifle innovation.

The scholars, Barbara Evans, Wylie Burke, and Gail Jarvik, from the Universities of Houston and Washington, wrote in a May 27

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