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 You are in: Under Secretary for Public Diplomacy and Public Affairs > Bureau of Public Affairs > Bureau of Public Affairs: Press Relations Office > Press Releases (Other) > 2004 > March 
Media Note
Office of the Spokesman
Washington, DC
March 26, 2004


Conference to Develop Safety, Efficacy, and Quality Principles for Fixed-Dose-Combination Drugs (FDCs)

A conference will be held on March 29-30, 2004 in Gaborone, Botswana in a step forward in the continuing global struggle against HIV/AIDS, tuberculosis and malaria. The purpose of the meeting is an attempt for the drug regulatory agencies of many nations and key international organizations to develop common principles to evaluate the safety, efficacy, and quality of fixed-dose-combination medications (FDCs) for use treating HIV/AIDS, tuberculosis, and malaria.

Co-sponsors of the conference are the Joint U.N. Programme on HIV/AIDS, the World Health Organization, the Southern African Development Community, and the U.S. Department of Health and Human Services. The goal of the co-sponsors and other collaborating organizations is to develop a set of commonly agreed-upon principles – based on current knowledge – which address the quality, safety, and efficacy of FDC therapy for the three diseases.

Representatives of the co-sponsors and other expert advisors met in Cape Town, South Africa this February to develop the first draft of the scientific and technical principles. The first draft of the Principles Document is available at http://www.globalhealth.gov/fdc.shtml. Those unable to attend the meeting should e-mail their comments on the draft Principles to aborlo@s-3.com.

Conference attendees will include government officials representing drug regulatory agencies from various nations, public health leaders, representatives of the research-based and generic pharmaceutical industry, health care providers, patient groups, academia and members of non-governmental organizations concerned with the care and treatment of these three diseases.

The Principles Document is not intended to address specific quality issues, or to develop clinical, therapeutic, or regulatory guidelines. The document will provide scientific and technical principles to consider when developing, evaluating, and/or considering FDCs for application in treatment programs.

The meeting is being held in the Gaborone Sun Hotel, in Gaborone, the capital city of Botswana. For more information go to http://www.globalhealth.gov/fdc.shtml.

2004/325

Released on March 26, 2004

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