Business · 29/11/2010Updated: 10/17/2026 · 1 min read

FDA Releases Guidance on Noninferiority Trials for Antibacterial Drug Products

Summary

The Food and Drug Administration has released a guidance document outlining its approach to using noninferiority trials to support the approval of antibacterial drug products, following a period of public discussion and evolution of the Agency's thinking in this area.

Original source language: Federal Register — Health and Human ServicesOpen original release →

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