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

July 31, 2014 5:28 PM

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

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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