Office of Infectious Diseases Research Activities
Antimicrobial Regulatory Science Research
Antimicrobial drug resistance is a major threat to public health. In March 2015, The National Action Plan for Combating Antibiotic-resistant Bacteria was developed in response to Executive Order 13676: Combating Antibiotic-Resistant Bacteria, which was issued on September 18, 2014. The updated National Action Plan for 2020 -2025 continues to outline steps for implementing the National Strategy for Combating Antibiotic-Resistant Bacteria to address urgent and serious drug-resistant threats (bacteria and fungi) that affect people in the U.S. and around the world. The updated Plan follows the framework of CDC’s 2019 AR Threats Report and uses the term “antibiotic” to describe antibacterial and antifungal drugs, which kill bacteria and fungi, respectively. Implementation of the National Action Plan will also support World Health Assembly resolution 67.25 (Antimicrobial Resistance), which urges countries to take urgent action at the national, regional, and local levels to combat resistance.
The FDA’s roles in combatting antimicrobial drug resistance include:
- Facilitating the development of new antimicrobial drugs to treat patients; and
- Advancing the science of clinical trial design. The design and conduct of clinical trials to evaluate new antimicrobial drugs in patients with serious bacterial and fungal infections is challenging and therefore of particular interest for FDA’s regulatory science program.
Background
FY26 Funding Opportunities
The FDA funds research proposals through FDA’s Broad Agency Announcement for the Advanced Research and Development of Regulatory Science. This is a competitive announcement where research proposals to facilitate antibacterial and antifungal drug development and address antibacterial and antifungal drug resistance are evaluated.
- Request for Proposals to Facilitate Development of Susceptibility Test Interpretive Criteria (STIC or Breakpoints) for Candida auris.
- Request for Proposals to Advance the Development of External Controls for Invasive Fungal Infection Trials.
Submissions are due by February 24, 2026
ORISE Fellowship Opportunities
- None currently available
Public Meetings
- Public Meetings (Upcoming and Past)
- CDER SBIA Webinar - Office of New Drugs (OND) Research: Seeking Collaborators, Funding Opportunities Available | November 6, 2020
- Advancing Animal Models for Antibacterial Drug Development | March 5, 2020
- Current State and Further Development of Animal Models of Serious Infections Caused by Acinetobacter baumannii and Pseudomonas aeruginosa | March 1, 2017