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Comparative efficacy data for new drugs, devices not required, FDA clarifies.

This article was originally published in The Tan Sheet

Executive Summary

COMPARATIVE EFFICACY DATA NOT REQUIRED IN NDAs and medical device premarket approval applications, FDA stated in an Aug. 1 Federal Register notice. Indicating that the document is a clarification of existing policy, FDA spelled out: "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." Public comments on the statement must be submitted by Oct. 30.
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