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This study examines how often medicines regulators in Australia, Canada, the United Kingdom, and the United States were concordant in their decisions to issue safety advisories on approved prescription medicines.
This Viewpoint describes current guidance for surrogate decision making for incarcerated patients who lack decisional capacity and gives recommendations on how to improve that guidance.
Key PointsQuestionWhen the US Food and Drug Administration approves cancer drugs based on response rate (RR) (ie, the percentage of patients whose cancer shrinks beyond an arbitrary threshold), what is the RR?
FindingsIn this review of 85 cancer drug indications approved on the basis of RR, the...
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