TAG:
clinical laboratory diagnostics
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…
Study Reveals Medicare Already Pays Low Rates
CEO SUMMARY: Researchers studied a database containing laboratory test prices paid in 2012 on behalf of 56 million Americans covered by private health plans and determined that, for most tests, and in most regions, Medicare already pays less than private health insurers for clinical labor…
CURRENT ISSUE
Volume XXXI, No. 16 – November 25, 2024
Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.
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