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  1. Center for Drug Evaluation and Research (CDER)

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 antibacterial drug resistance include:

  • Facilitating the development of new antibacterial drugs to treat patients; and
  • Advancing the science of clinical trial design.  The design and conduct of clinical trials to evaluate new antibacterial drugs in patients with serious bacterial infections is challenging and therefore of particular interest for FDA’s regulatory science program.

Background

FY25 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 on an ongoing basis throughout the fiscal year.

It’s recommended that potential Offerors attend FDA BAA Day on November 14, 2024, to learn about the BAA submission process.

ORISE Fellowship Opportunities

Public Meetings

Related Resources

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