EMA: Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections

Guidance on evaluation of medicinal products indicated for the treatment of bacterial infections(CPMP/EWP/558/95 Rev 2) has been adopted. It provides details of requirements for clinical studies intended to support specific indications that are commonly sought and the evaluation of antibacterial agents with potential to be active against rare and/or difficult to treat bacterial pathogens, including organisms that are resistant to many of the available agents.