Comparisons of effectiveness not required for new drugs and devices -- FDA "ReGo" notice.
DRUG/DEVICE EFFECTIVENESS COMPARISONS NOT REQUIRED in NDAs and premarket approval applications, FDA stated in an Aug. 1 Federal Register notice. Indicating that the notice is a clarification of existing policy, FDA said: "The agency does not require new human drug products or medical devices to be more effective than existing therapies nor does it necessarily require the product be compared to other products."
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