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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers. FDA’s position is, however, only one side of the story.

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Once again, the Agency for Healthcare Research and Quality is in the line of fire

Common Sense Family Doctor

Dubbed " the little federal agency that could ," AHRQ has accomplished this feat with a small fraction of the budgets of its higher-profile cousins, the Centers for Disease Control and Prevention and the National Institutes of Health. This is research and evidence that no one, healthy or ill, can afford to lose. Why should you?