Reviving old antibiotics: Colistin SPCs
March 15, 2014 1 Comment
Colistin is arguably the first case in the antibacterial field where substantial “re-development” activities have been driven by academic and clinical investigators, rather than a sponsoring company. As a result of these activities, there is rapidly evolving new non-clinical and clinical knowledge on colistin. My recently published study investigated the variation and accuracy of information in the summary of product characteristics (SPCs) of intravenous colistin products approved in the European Union. This study highlights the challenges of integrating new rapidly evolving scientific knowledge into approved SPCs in Europe.
More information on regulatory issues of colistin: http://epasg.escmid.org