EMA Draft addendum to the guideline on the Evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements (EMA/CHMP/187859/2017)

As part of its advocacy program in Europe, ACRO submits regulatory comments to European officials. This comment letter, submitted by ACRO to EMA in 2018 about EMA Draft addendum to the guideline on the Evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements (EMA/CHMP/187859/2017) can be found below.

EMA Draft addendum to the guideline on the Evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements (EMA/CHMP/187859/2017)

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