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Enforcement Guidance Clinical Laboratories

Wilson Sonsini Goodrich & Rosati

FDA Issues Notice to Congress of Its Intent to Comprehensively Regulate Laboratory Developed Tests (LDTs)

On July 31, 2014, the U.S. Food and Drug Administration (FDA) "pre-published" its proposed new plan to regulate laboratory developed tests (LDTs). In letters to the U.S. Senate and the House of Representatives, the FDA...more

Foley Hoag LLP

FDA Unveils Anticipated Draft Guidance for the Regulation of Laboratory-Developed Tests

Foley Hoag LLP on

On July 31, 2014, the Food and Drug Administration (FDA) provided Congress notice of its intent to issue draft guidance providing a risk-based framework for the regulation of laboratory developed tests (LDTs) under the...more

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