EMA Proposes Single Guide for Clinical Evaluations of Bacterial Infection Treatments

The European Medicines Agency proposes to merge two guidances on clinical evaluations of bacterial infection treatments to reflect the latest scientific advice from its Committee for Medicinal Products for Human Use.

The CHMP called for an update to “clarify the preferred and less favored options for clinical programs with antibacterial agents expected to address an unmet need.”

The CHMP’s infectious disease working group also recommended the clarification of clinical data requirements used to support new combinations of known beta-lactam agents with new beta-lactamase inhibitors and the clarification of considerations for accepting single pivotal studies to support infection site-specific and pathogen-specific indications.