EMA: Guideline on the Evaluation of Medicinal Products indicated for treatment of bacterial infections
08.04.2010
This guideline considers the microbiological and clinical data required to support indications, dose regimens and durations of therapy for antibacterial agents and the layout and wording of some sections of the Summary of Product Characteristic.
The source of the news: http://www.ema.europa.eu/pdfs/human/ewp/055895endraftrev2.pdf
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