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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.
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
Publishing peer-reviewed studies to tout the economic benefits of medical devices is fairly commonplace, but rare for a laboratory company
Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests