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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
CMS Issues Deficiency Letter to Theranos
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Know What’s Really Going On
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Focus Medical Necessity Efforts on Three Core Elements
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News at a Glance – Feb 2016
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Long-Awaited Final Rule Clarifies 60-day Repayment Deadline
From - G2 Compliance Advisor
Labs and other providers are required by a provision enacted in the Affordable Care Act to return to Medicare overpayments within 60 days of…
Walgreens Tells Theranos to Fix Problems or Lose Pact
From - Laboratory Industry Report
Walgreens has told Theranos to get its act together, or get out…
Shire and ACMG Partner to Support Medical Geneticist Training
From - National Intelligence Report
"As a result of advances in the area of genetic and genomic research and diagnostic testing, it is anticipated that the need for…
Guidelines for Zika Testing and Safety Issued
From - National Intelligence Report
The Zika virus is getting increased attention from U.S. media and the Centers for Disease Control and Prevention (CDC) now that the first case of the infection has been detected in a…
