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
Links
Center
for Veterinary Medicine Antimicrobial Resistance Page
Upcoming CDER Advisory
Committee Meetings
|
