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Jun, 2022
EMA updates guideline on the treatment of bacterial infections
The European Medicines Agency (EMA) has published the final revised guideline on the evaluation of human medicines for the treatment of bacterial infections. The revised guideline reflects the outcome of recent discussions between regulators in the EU, United States and Japan on the development of new antimicrobial medicines. Among others, it includes recommendations on the clinical criteria for patient enrolment, the primary endpoint and the primary analysis in infection site-specific trials. Antimicrobial resistance (AMR) is a global threat that puts children’s health at great risk. WHO estimates that infections caused by multi-drug […]