FDA Will Not Finalize Guidance On Laboratory Developed Tests

November 18, 2016 at 3:55 PM
Updated Story FDA is putting the breaks on finalizing its controversial laboratory developed test guidance, according to an email, obtained by Inside Health Policy, from Katherine Serrano, deputy director of the Division of Chemistry and Toxicology Devices in FDA's device center. The agency's October 2014 draft guide if finalized would have set in motion FDA oversight over LDTs including notification, approval and reporting requirements for laboratories. Serrano wrote in the email: “The FDA believes that patients...

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