Tag: american clinical laboratory

Court Dismisses ACLA Claims in PAMA Case

CEO SUMMARY: While acknowledging that the American Clinical Laboratory Association raises important questions in its case against the federal Department of Health and Human Services, a district court judge ruled that the court cannot resolve the dispute and dismissed the ACLA’s claims for lack of “subject matter jurisdiction.” While not dismissing it outright, the judge

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FDA Issues Response to Draft Legislation to Regulate LDTs

DURING HER ADDRESS TO THE ANNUAL MEETING of the American Clinical Laboratory Association meeting in March, Rep. Diana DeGette (D-Colo.) explained why she and others in Congress had developed the Diagnostic Accuracy and Innovation Act (DAIA), a discussion draft that would give the FDA authority to regulate laboratory developed and in vitro diagnostic tests. At

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