TAG:
clinical laboratory diagnostics
FDA Issues Response to Draft Legislation to Regulate LDTs
By Joseph Burns | From the Volume XXV No. 12 – August 20, 2018 Issue
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
By Joseph Burns | From the Volume XX, No. 17 – December 23, 2013 Issue
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
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Volume XXXI, No. 10 – July 22, 2024
An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.
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