Addendum to the Guideline on the Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections to Address Paediatric-specific Clinical Data Requirements

On 24 May 2022 the EMA published the addendum to the guideline on evaluation of medicinal products indicated for treatment of bacterial infections.

This addendum to the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 3) has been developed to provide guidance on clinical development programmes that are required to support the authorisation of antibacterial agents for treatment of infectious diseases in paediatric patients.

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