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Manufacturers › Laboratory Developed Tests › Pharmaceutical Industry

Troutman Pepper

FDA Issues Final Rule on Regulation of Laboratory Developed Tests

Troutman Pepper on

After many years of anticipation and various congressional and agency proposals, on May 6, the Food and Drug Administration (FDA) published its final rule titled "Medical Devices; Laboratory Developed Tests." The final rule...more

Sheppard Mullin Richter & Hampton LLP

FDA Makes Good on Its Promise to Regulate Laboratory-Developed Tests

Sheppard Mullin Richter & Hampton LLP on

Yesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and highly controversial – final rule, which rolls out a four-year, five-stage plan that will phase out the Agency’s previous...more

Jones Day

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

Jones Day on

The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

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