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FDA, EMA, PMDA to align clinical trial designs for antibacterial drugs

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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