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Multidrug-resistant (MDR) pathogens cause significant morbidity and mortality in neonates, infants, and children. In order to deliver critically needed new treatments for these infections, safety and efficacy are evaluated by regulators and are also considered by children and their parents, prescribers, and drug developers. Regulatory approval is granted when the benefit-risk profile is acceptable, and risks and benefits are communicated in the labeling of the approved product. However, with greater severity of the infection, consequences of inadequate treatment, and the lack of effective therapy, patients and physicians are generally willing to accept greater risks and side effects from treatment.