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 also participates on the Public Health Service Task Force on Antimicrobial Resistance (PHS Draft Public Health Action Plan to Combat Antimicrobial Resistance: Action Plan and Federal Register Notices).
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 (CDER organizational map).
Antibacterial Resistance and Diagnostic Device and Drug Development Research for Bacterial Diseases, Public Workshop; July 26-27, 2010[ARCHIVED] 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 Antimicrobial Resistance & Drug Development FDA/IDSA/ISAP Working Group Presentations and Transcripts April 15-16, 2004
Guidances (Drugs) Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment(PDF - 144KB) Acute Bacterial Otitis Media: Developing Drugs for Treatment(PDF - 117KB) Acute Bacterial Sinusitis — Developing Antimicrobial Drugs for Treatment(PDF - 480KB) Community-Acquired Pneumonia — Developing Antimicrobial Drugs for Treatment(PDF - 230KB) Influenza: Developing Drugs for Treatment and/or Prophylaxis(PDF - 417KB) Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices(PDF - 143KB)
Additional FDA Information
- Get Smart About Antibiotics
Information for consumers on antibiotics and antibiotic resistance
- Report: Estimates of Antibacterial Drugs Use in Human Medicine
Center for Veterinary Medicine
- Public Health Focus: Antimicrobial Resistance
Combating Antibiotic Resistance
FDA Consumer Update