FDA Watch: New Policy Would Allow DTC Marketing of Genetic Tests without Premarket Approval

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Dec 5, 2017

INDUSTRY BUZZ
FDA Watch: New Policy Would Allow DTC Marketing of Genetic Tests without Premarket Approval
From - Laboratory Industry Report
For years, the lab industry has been pressing the FDA to relinquish its rigorous oversight of direct-to-consumer (DTC) genetic health tests…
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		COMPLIANCE CORNER Medicare Exclusions: One Week, Two Different Labs Get the Boot From - G2 Compliance Advisor Exclusion of a clinical lab from participating in Medicare or other government health programs is a relatively rare penalty… Read More

TOP OF THE NEWS
Malpractice Lawsuit Calls Out Lack of Genetic Counseling
From - Diagnostic Testing & Emerging Technologies
A 36-year-old Oregon woman filed a $1.8 million medical malpractice lawsuit against her doctors and a southwest Oregon medical center for…
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PAMA
CMS Ignores Flawed Processes, Finalizes 2018 PAMA Pricing; Labs Need to Take Immediate Action to Offset Impending Lean Times
From - G2 Blog
The final 2018 clinical laboratory fee schedule (CLFS) is out, and it is evident that the argument that the…
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