Q&A: Lawyer Jeff Gibbs On Future of FDA Regulation of Lab-Developed Tests Under New Administration

Nov 29, 2016

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NEW YORK (GenomeWeb) – The US Food and Drug Administration has said it is delaying finalizing regulatory guidelines for lab-developed tests (LDTs), but people closely following the decades-long controversy believe that the draft document released two years ago is dead in the current political climate.

This is welcome news for those in the lab industry that have fought the FDA's every attempt, over more than 20 years, to regulate LDTs under the device law.

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