FDA To Regulate Thousands Of Cancer, Genetic, And Other Diagnostics

July 31, 2014 5:28 PM

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The Food and Drug Administration unveiled plans to regulate thousands of diagnostic tests, including many coming from the exploding field of genetic research, to which it has until now turned a blind eye.

More than 11,000 of these tests, known as laboratory-developed tests, created by 2,000 different laboratories, could be included in the new regulatory framework, according to the FDA. The agency made its plans public in a guidance document that was sent to Congress, as part of legal direction by leg...

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