FDA issues final guidance for antibacterial streamlined program

FDA published guidance for companies developing new antibacterial drugs. The guideline presents possible streamlined development programs and clinical trial designs for antibacterial drugs to treat serious bacterial diseases in patients with an unmet medical need, including patients who have a serious bacterial disease for which effective antibacterial drugs are limited or lacking.

Candidates for a streamlined program include, among others, products with an affed inhibitor that neutralize resistance or an alteration in molecule structure that limits reistance.

For more details, guidance are available here.

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The NAREB project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 604237.