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Antimicrobial Resistance

Welcome to the CDER Antimicrobial Resistance Home Page. FDA, in cooperation with other Public Health Service Agencies, has embarked on 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 is designed to permit ready access to FDA and CDER activities, initiatives, policies, and information regarding antimicrobial resistance (also known as drug resistance or antibiotic resistance), both for health professionals and consumers. General and technical information on antimicrobial resistance is also available at the Centers for Disease Control (CDC) Antimicrobial Resistance Web Site. This CDC web site has an extensive catalog of information about antimicrobial resistance, including fact sheets about specific pathogens and published clinical guidelines.

Since 1996, FDA has actively addressed the issue of antimicrobial resistance through several major initiatives. As an agency composed of several separate centers, including the Center for Veterinary Medicine (CVM), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health, and the Center for Food Safety and Nutrition, FDA has addressed antimicrobial resistance through a variety of initiatives.  These initiatives include an agency-wide cooperative effort, the FDA Task Force on Antimicrobial Resistance, specific activities within each center, and participation 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, the Center for Drug Evaluation and Research, is home to (among others) the Divisions of Anti-Infective Drug Products, Special Pathogen and Immunologic Drug Products, Antiviral Drug Products (all within the Office of Drug Evaluation IV), the Division of Over-the-Counter Drug Products (within the Office of Drug Evaluation V), and the Office of Generic Drugs.  These offices all have involvement in FDA's efforts to address antimicrobial resistance. (CDER organizational map)
FR Notice: Anti-Infective Drugs Advisory Committee Meeting October 14, 2004. The committee will discuss the following topics: 1. Issues related to clinical trial design and analysis in studying catheter-related bacteremia and 2. issues related to clinical trial design and analysis in studying bacteremia due to staphylococcus aureus.
  • Federal Register Notice  [TXT] [PDF]

FR Notice: A Public Health Action Plan To Combat Antimicrobial Resistance (Part I: Domestic Issues): Meeting for Public Comment on the Antimicrobial Resistance Interagency Task Force Annual Report

  • Federal Register Notice [Text] or [PDF]

FDA/IDSA/ISAP Working Group Meeting Presentations and Transcripts (5/7/2004)

Posting to assist stakeholders in complying with the Final Rule (Word Document) (8/19/2003)

News: FDA Publishes Final Rule to Require Labeling about Antibiotic Resistance (3/5/2003)

Antimicrobial Resistance Archive

Center for Veterinary Medicine Antimicrobial Resistance Page

Upcoming CDER Advisory Committee Meetings


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FDA/Center for Drug Evaluation and Research
Last Updated: September 12, 2006
Originator: OTCOM/DLIS