AACR Issues Policy Statement Underscoring Importance of Safe, Accurate, Effective Diagnostic Tests

The American Association for Cancer Research (AACR) recently issued a policy statement that underscores the importance of safe, accurate, and effective diagnostic tests by recommending that the U.S. Food and Drug Administration (FDA) begin to actively exert its authority to regulate high-risk laboratory developed tests (LDTs) that are being utilized by physicians to make treatment decisions, including the tailoring of an individual’s cancer treatment regimen.

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A Culture of Safety at the CDC

I had the radio on as I drove to the market, but I wasn’t really listening until I heard “It’s very important to have a culture of safety that says, if you’ve got a problem, talk about it.” I didn’t recall ever having heard the phrase “culture of safety” outside of safety improvement circles.

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FDA Guidance on Medical Devices for Home Use

Home use of medical devices includes both prescription and over-the-counter products. Among prescription devices, some may be intended by the manufacturer to be used at home, and others may not have that intent but are provided nonetheless to patients by or through prescribers. All home use devices raise basic questions.

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