FDA Guidance for Industry: Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases

On August 1, the U.S. Food and Drug Administration (FDA) released a new Guidance for Industry, “Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases.” The guidance is not binding or legal, but is a recommendation for those working to develop or support the development of new pathogen-focused antibacterial drugs and presents opportunities to streamline development to have medications available for those with unmet medical needs. This and similar guidance, programs, and incentives are part of a broader international approach to facilitate and encourage the development of new options in the face of the growing threat of antimicrobial resistance. Click here to access the full report and learn more.

About Christina Baum

Christina Baum serves as a Program Analyst for infectious disease at NACCHO. Her work includes projects on surveillance, epidemiology, and emerging infectious diseases.

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