TAG:
fda ldt guidance
New Twist: HHS Exerts Authority Over FDA on LDTs
CEO SUMMARY: In a recent memo, the federal Department of Health and Human Services’ general counsel rendered a legal opinion that FDA would need to issue new regulations to regulate LDTs. By stepping into this years-long dispute and saying that FDA cannot regulate LDTs through gui…
LabCorp Now Larger than Quest, Two Labs Report 2015 Earnings
IN RECENT WEEKS, the nation’s two largest lab companies reported fourth quarter and full-year earnings for 2015. The earnings reports reveal how the paths of the two companies are diverging. The companies are diverging because of a major acquisition made in February 2015, by Laboratory Cor…
Official Makes Case in Favor of FDA LDT Guidance
IN THIS EXCLUSIVE NEWS COVERAGE of a public appearance by a key FDA official, THE DARK REPORT provides lab executives and pathologists with a more nuanced understanding about the thinking behind the proposed …
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Volume XXVIII, No. 6 – May 3, 2021
As Millennials become set to dominate the workforce and national life, The Dark Report analyzes their preferences as consumers and how those preferences will change healthcare. Also in this issue is a report on how a federal court affirms that paying sales contractors commissions violates the Anti-Kickback Statute.
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