Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections

June 13, 2018 – This concept paper proposes the development of a single guideline on the clinical evaluation of medicinal products indicated for treatment of bacterial infections. The development of this single guideline is intended to merge, revise and add to the guidance that is currently included in two separate documents as follows: guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95/ Rev 2) … (leggi tutto)