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Policy commentary reveals insufficient institutional reform in FDA drug oversight, highlighting persistent barriers to establishing a robust culture of safety.
In a 2006 report, the Institute of Medicine implored the FDA to “embrace a culture of safety” by increasing the priority accorded to the safety of patients. Sheila Weiss Smith writes that the FDA's response to the IOM report demonstrates a lack of understanding of the magnitude of the changes required to create a culture of safety.
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Sheila Weiss Smith (2007) studied this question.
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