Bridging the gap between urinary tract infection pharmacokinetic/pharmacodynamic in vitro models and the optimization of antibiotic selection, dosing strategies, clinical breakpoints, and novel drug development

Request for Full Proposal, Broad Agency Announcement for the U.S. Food and Drug Administration (FDABAA-23-00123) in response to Research Funding Opportunity to Evaluate the Utility of In Vitro Models to Characterize the Urine-Specific Antibacterial Pharmacokinetics and Pharmacodynamics through the FDA Broad Agency Announcement

The FDA Broad Agency Announcement (FDABAA-23-00123) is an open solicitation for research and development to support regulatory science and innovation.

In fiscal year 2023, the following research area under FDABAA-23-00123 has been identified as a priority area by the Office of Infectious Diseases in FDA’s Center for Drug Evaluation and Research:
• Charge Area: III. Invigorate public health preparedness and response of the FDA, patients, and consumers.
• Regulatory Science Topic Area of Interest: B. Antimicrobial Resistance
• FDA-Regulated Areas: 1. Drugs
o 1b - Advance the science of in vitro, animal model, pharmacokinetic studies, and/or real- world evidence studies to facilitate drug development, including studies focused on antifungal and antibacterial resistance and drug development for special populations such as patients with unmet need, children and patients with renal or hepatic dysfunction

Specifically, research proposals focused on evaluating the utility of in vitro models to derive urine-specific antibacterial pharmacokinetic/pharmacodynamic parameters in support of drug development for uncomplicated urinary tract infections will be prioritized.

White Paper submitted Jan 23, 2023, and FDA requesting Full Proposal submission