EMA: Draft concept paper on an addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev. 2) to address paediatric-specific clinical data requirements

This concept paper proposes the development of an addendum to the guideline on the evaluation of new anti-bacterial medicinal products (CPMP/EWP/558/95 Rev. 2) to address the clinical development of antibacterial medicinal products for use in the paediatric population.

Posted on the EMA website on 20 April 2016