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  1. Center for Drug Evaluation and Research | CDER

Office of Antimicrobial Products Research Activities

Antimicrobial Regulatory Science Research

Antibacterial 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 National Action Plan outlines steps for implementing the National Strategy for Combating Antibiotic-Resistant Bacteria to address urgent and serious drug-resistant threats that affect people in the U.S. and around the world.  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.

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  • No Fellowship Opportunities Currently Available

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