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
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Recent Case Highlights Importance of Where Whistleblowers Get Info
What happens when a whistleblower’s case is based on information that’s already been publicly disclosed?
Three Key Changes Your Lab Staff Need to Know About
CMS recently announced some important changes affecting PAMA price reporting, along with a list of 17 new PLA codes that will be recognized.
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