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Antibiotic Non-Inferiority Trials To Be Addressed By FDA Advisory Committee

Executive Summary

Antibiotic drug sponsors may get more clarity on FDA's policy for non-inferiority margins following the conclusion of a three-day Anti-Infective Drugs Advisory Committee meeting in November

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Patient Dropouts, Other “Missing Data” To Be Addressed In FDA Guidance

FDA hopes two guidances - one on non-inferiority margins and another on how to handle missing data in clinical trials - will better direct industry in developing clinical trials and extrapolating more accurate data

Guidance on Anti-Infective Non-Inferiority Margins May Not Be Clear-Cut

FDA is expected to provide some much-desired clarity on its policy for non-inferiority margins in clinical trials for anti-infectives at this week's advisory committee meeting. But the end result may not be the concrete answer that industry is hoping for

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