FDA Postpones Release of Highly Anticipated Final Guidance on Regulating Laboratory-Developed Tests

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FDA Postpones Release of Highly Anticipated Final Guidance on Regulating Laboratory-Developed Tests

Dennis Tosh

Guide to Medical Device Regulation

November 22, 2016 at 06:12 AM EST

The FDA announced Nov. 18 that it is putting on hold the release of highly anticipated final guidance on the agency’s regulation of laboratory-developed tests (LDTs), saying that it will work with the new administration and Congress to help determine how the agency may exercise expanded oversight of the tests. “The FDA believes that patients and health care providers need ac... Read More

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FDA Postpones Release of Highly Anticipated Final Guidance on Regulating Laboratory-Developed Tests

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