August 2024 Labs in Court
COVID-19-related schemes dominated recent enforcement efforts, which include a national healthcare fraud enforcement action
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ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
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July 2024 Labs in Court
Genetic testing related fraud was a theme in recent enforcement actions involving medical laboratories and lab testing
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FDA Issues Four Warning Letters to Lab Companies in Less Than Two Months
Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests
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May 2024 Labs in Court
Recent enforcement actions and court cases include kickback schemes a-plenty and a reminder to focus on HIPAA compliance
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