Antimicrobial Resistance Information for 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
- July 18-19, 2016: Facilitating Antibacterial Drug Development for Patients with Unmet Need and Developing Antibacterial Drugs that Target a Single Species
- September 29, 2016: Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
- September 15, 2016: Anti-Infective Drug Development in Neonates
- October 15, 2015: Public Meeting on Patient-Focused Drug Development for Nontuberculous Mycobacterial Lung Infections
- March 31, 2014: Anti-Infective Drugs Advisory Committee Meeting to discuss two new drug applications for treatment of Acute Bacterial Skin and Skin Structure Infection
- October 17, 2013: Anti-Infective Drugs Advisory Committee Meeting to discuss susceptibility interpretive criteria for systemic antibacterial drugs
- November 29, 2012 Anti-Infective Drugs Advisory Committee Meeting to discuss a new drug application for treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
- November 28, 2012 Anti-Infective Drugs Advisory Committee to discuss a new drug application for treatment of pulmonary tuberculosis
- November 4, 2012 Anti-Infective Drugs Advisory Committee Meeting to discuss clinical trial design issues in the development of antibacterial drugs for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
- November 3, 2012 Anti-Infective Drugs Advisory Committee Meeting to discuss clinical trial design issues in the development of antibacterial drugs for the treatment of community-acquired bacterial pneumonia
- September 7, 2010 Anti-Infective Drugs Advisory Committee Meeting to discuss a new drug application for treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infection
- December 9, 2009: Anti-Infective Drugs Advisory Committee Meeting to discuss endpoints and clinical trial design issues in the development of antibacterial drugs for treatment of community-acquired bacterial pneumonia
- October 26, 2009: Anti-Infective Drugs Advisory Committee Meeting to discuss updating susceptibility test information in systemic antibacterial drug product labeling
- June 2, 2009: Anti-Infective Drugs Advisory Committee Meeting to discuss a new drug application for treatment of community-acquired bacterial pneumonia
- November 18-20, 2008: Meeting of the Anti-Infective Drugs Advisory Committee to discuss the noninferiority margin justification for complicated skin and skin structure infection and to discuss three new drug applications for treatment of complicated skin and skin structure infection
Workshops
- Current State and Further Development of Animal Models of Serious Infections Caused by Acinetobacter baumannii and Pseudomonas aeruginosa; March 1, 2017
- Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices; September 29, 2016
- Anti-Infective Drug Development in Neonates; September 15, 2016
- Facilitating Antibacterial Drug Development for Patients with Unmet Need and Developing Antibacterial Drugs that Target a Single Species; July 18 and 19, 2016
- Clinical Trial Design Considerations for Malaria Drug Development; June 30, 2016
- Public Workshop on the Clinical Development of Drugs to Prevent Infections Caused by Staphylococcus Aureus in the Healthcare Setting; September 5, 2014
- The Development of New Antibacterial Products: Charting a Course for the Future; Public Workshop July 30 â 31, 2014
- Issues in the Design and Conduct of Clinical Trials for Antibacterial Drug Development, Public Workshop; August 2, 2010
- Issues in the Design and Conduct of Clinical Trials for Antibacterial Drug Development, Public Workshop; August 3, 2010
- Antibacterial Resistance and Diagnostic Device and Drug Development Research for Bacterial Diseases, Public Workshop; July 26-27, 2010
- Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia; Public Workshop March 31 - April 1, 2009
- Clinical Trial Design for Community-Acquired Pneumonia; Public Workshop January 17-18, 2008
- Clinical Trial Design for Community-Acquired Pneumonia; Public Workshop
Guidance Documents
- Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment
- Acute Bacterial Otitis Media: Developing Drugs for Treatment
- Acute Bacterial Sinusitis â Developing Antimicrobial Drugs for Treatment
- Community-Acquired Pneumonia -- Developing Antimicrobial Drugs for Treatment
- Influenza: Developing Drugs for Treatment and/or Prophylaxis
- Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices
- Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment
- Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval
- Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases
- Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment
- Complicated Urinary Tract Infections: Developing Drugs for Treatment
- Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment
- Microbiological Data for Systemic Antibacterial Drug Products â Development, Analysis, and Presentation
- Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention
- Complicated Intra-Abdominal Infections: Developing Drugs for Treatment
- Uncomplicated Gonorrhea: Developing Drugs for Treatment
- Pulmonary Tuberculosis: Developing Drugs for Treatment
Additional FDA Information
- Antimicrobial Resistance Information from FDA
- Get Smart About Antibiotics
- Report: Estimates of Antibacterial Drugs Use in Human Medicine
- Antimicrobial Resistance
- Animal
- Public Health Focus: Antimicrobial Resistance
- Combating Antibiotic Resistance
- Antibacterial and Antifungal Product Labeling: Microbiology Susceptibility Interpretive Criteria (Breakpoints) and Quality Control Parameter Updates
- Analytical Framework for Examining the Value of Antibacterial Products, April 2014