FDA Watch: Agency Launches Database of Complete Response Letters Sent to Drug Manufacturers About Initial Rejections
The early focus is on drug applications, but it could spread to the laboratory test approval process as well
National Lab Reporter
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Articles and Reports
Federal Appellate Decision on EKRA Spells Out How Lab Marketers Can Violate the Law
If clinical lab managers instruct marketing personnel to engage in kickback practices, they also could be held legally accountable
CMS Clarifies CLIA Personnel Requirements in Rare Memo
Clinical labs gain flexibility in meeting regulatory standards while potentially reducing their costs
Don’t Use These Rapid COVID-19 Tests, FDA Warns
The US Food and Drug Administration recently issued a letter warning people not to use two different tests produced by Empowered Diagnostics.
Feds False Claim Recoveries Top $5.6 Billion
The cost of recoveries hit an eight-year high in FY 2021, with the health care industry footing 90 percent of the bill.
COVID-19 Testing Drives Increase in Part B Medicare Lab Spending
Here’s a look at the key takeaways from the Dec. 30 OIG report on Medicare Part B spending on lab testing.
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Federal Enforcers Crack Down on Fraudulent Billing of Genetic Tests
Labs that bill federal health care programs for these tests need to pay especially close attention to ensure compliance.
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FY 2021 OIG Enforcement Outcomes Continue Long-Term Downward Trend
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