Antimicrobial Resistance Information for health professionals and Consumers and Health Professionals

FDA, in cooperation with other Public Health Service Agencies, has been involved in several major initiatives to address what is considered to be a major threat to the Public Health in the new millennium: the emergence of drug-resistant bacteria.

This page provides access to FDA and CDER (Center for Drug Evaluation and Research) activities, initiatives, policies, and information regarding antimicrobial resistance (also known as drug resistance or antibiotic resistance) for health professionals and consumers. Extensive information on antimicrobial resistance, including fact sheets about specific pathogens and published clinical guidelines, is also available at the Centers for Disease Control (CDC) Antimicrobial Resistance website.

As an agency composed of several centers, including the Center for Veterinary Medicine, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and the Center for Food Safety and Nutrition, FDA has been involved in a variety of initiatives related to antimicrobial resistance. FDA participates on the Public Health Service Interagency Task Force on Antimicrobial Resistance (A Public Health Action Plan to Combat Antimicrobial Resistance: 2012 Update).

CDER's Divisions of Anti-Infective Products, Transplant and Ophthalmology Products, Antiviral Drug Products (all within the Office of Antimicrobial Products), Division of Over-the-Counter Drug Products, and Office of Generic Drugs are involved in FDA's efforts to address antimicrobial resistance.

September 1-2, 2016: FDA participated in a meeting with the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA, Japan) to discuss regulatory approaches for the evaluation of antibacterial agents. The EMA, PMDA, and FDA consider that a robust response to the problem of antimicrobial resistance must be multi-faceted and that the regulatory approach for the evaluation of antibacterial agents is only one element of the total response that is required to encourage and  accelerate new antibacterial drug development to meet patient needs. Meeting summary (PDF, 135 KB)

Advisory Committee Meetings

Guidance Documents

Additional FDA Information

Page Last Updated: 09/12/2016
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