FDA establishes pilot program to reduce risks associated with cancer biomarker laboratory developed tests

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FDA established a voluntary pilot program for certain oncology drug products used with certain corresponding in vitro diagnostic tests to help clinicians select appropriate cancer treatments for patients.

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Vinay Prasad, FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, has instructed his staff to check with him before continuing to work on ongoing submissions to journals or beginning new contract-funded projects to “ensure that we are not engaging in sunk cost fallacy, not publishing obviously erroneous work, and not being distracted from our core mission.”

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