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FDA Shows When And How To Use, Or Not To Use, Non-Inferiority Trials

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA’s eagerly awaited draft guidance on non-inferiority trials should facilitate greater, and easier, use of such trials. It even allows for the possibility of using a non-inferiority design for a single supportive pivotal trial, especially if the trial uses a definitive endpoint like an outcomes assessment.

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