Press Release: New EMA guidance on development of antibacterials to help in the fight against multidrug-resistant pathogens

Author (Corporate)
Series Title
Series Details EMA/682305/2013 (07.11.13)
Publication Date 07/11/2013
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The European Medicines Agency (EMA),on 7 November 2013, released an Addendum to the guideline on the evaluation of medicinal products indicated for the treatment of bacterial infections. One of the most important aspects of the addendum is that it outlines a new approach facilitating the development of antibacterial agents targeted against multidrug-resistant (MDR) pathogens where patients have very limited or no remaining treatment options. It also gives guidance on data-gathering strategies to support the benefit-risk evaluation as part of the marketing-authorisation process for different indications.
Source Link http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/11/news_detail_001944.jsp&mid=WC0b01ac058004d5c1
Related Links
EMA: Press Release: EMA/682305/2013 (07.11.13): New EMA guidance on development of antibacterials to help in the fight against multidrug-resistant pathogens http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/11/WC500153968.pdf
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