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FDA to hold August workshop on non-inferiority studies of antibacterial drugs

This article was originally published in Scrip

Executive Summary

The US FDA plans to hold a two-day workshop beginning on 2 August which will focus on the design and conduct of non-inferiority (NI) clinical trials which are often used in the evaluation of the safety and efficacy of new antibacterial drugs. Presentations are expected from both FDA officials and various stakeholders.

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