Office of Infectious Diseases Research Activities

Why It Matters

These grants accelerate the development of new antimicrobials and improve trial designs, directly addressing a growing public‑health threat and creating market opportunities for biotech firms. Aligning with the National Action Plan ensures coordinated federal action against resistance.

Key Takeaways

• FY26 FDA funding deadline: Feb 24, 2026 for antimicrobial research
• Proposals target Candida auris breakpoint criteria and fungal trial controls
• National Action Plan 2020‑2025 guides U.S. antimicrobial resistance strategy
• FDA aims to improve clinical trial designs for serious infections
• No ORISE fellowships currently available in infectious diseases

Pulse Analysis

Antimicrobial resistance remains one of the most urgent health challenges of the 21st century, prompting the U.S. government to adopt a comprehensive National Action Plan for 2020‑2025. The plan builds on the 2015 strategy and aligns with World Health Assembly resolution 67.25, urging coordinated action across federal agencies, industry, and academia. Within this framework, the FDA’s Office of Infectious Diseases plays a pivotal regulatory‑science role, facilitating the pipeline for new antibacterial and antifungal agents while refining clinical‑trial methodologies that reflect real‑world infection scenarios.

For fiscal year 2026, the FDA is issuing a competitive Broad Agency Announcement to fund research that tackles two critical gaps: establishing susceptibility‑test interpretive criteria for the emerging pathogen Candida auris and developing external controls for invasive fungal infection trials. These focus areas address both diagnostic precision and trial robustness, essential for bringing effective therapies to market faster. By setting clear milestones and offering financial support, the agency aims to lower development costs for biotech firms and accelerate the approval of drugs that can outpace evolving resistance patterns.

Beyond funding, the FDA continues to convene public meetings that shape the scientific discourse on animal models and infection dynamics, fostering collaboration among regulators, researchers, and industry stakeholders. The absence of current ORISE fellowships signals a shift toward external research partnerships rather than in‑house training. As antimicrobial resistance escalates, the agency’s strategic investments and open‑dialogue platforms will be crucial for sustaining a pipeline of innovative treatments and safeguarding public health.