www.fdanews.com/articles/191515-ema-offers-early-dialogue-with-sponsors-of-new-antimicrobials
EMA Offers Early Dialogue With Sponsors of New Antimicrobials
June 4, 2019
The European Medicines Agency is inviting early dialogue with its Innovation Task Force (ITF) for sponsors of antimicrobial products for treatment or prevention of bacterial and fungal infections.
The task force is usually reserved for innovative medicines, but the agency is inviting sponsors of any new antimicrobials to reach out early “given the growing threat to public health caused by antimicrobial resistance and the need for new treatments.”
Approximately 700,000 individuals die from drug resistant infections globally each year, according to the World Health Organization. The EMA says that stimulating the development of new medicines to treat resistant bacterial or fungal infections is “a high priority” at the agency.