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FDA, EMA, PMDA to align clinical trial designs for antibacterial drugs
11/7/2019

The FDA, the European Medicines Agency and Japan's Pharmaceuticals and Medical Devices Agency recently met to align clinical study designs for antibacterial drugs so that a single development program could meet the requirements for all three regulators. The agencies also discussed alignment on antifungal development, anti-infective drugs for children, differences in susceptibility testing and trial considerations for new types of therapies.

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