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Office of Special Health Issues
Frequently Asked Questions

Last Revised March 11, 2003

Does FDA have a central Web page for HIV/AIDS information?

The Office of Special Health Issues has established an HIV and AIDS page: www.fda.gov/oashi/aids/hiv.html. It contains hyperlinks to FDA documents relating to HIV Testing, Barrier Products, News Releases, Upcoming Meetings, Status of HIV/AIDS Therapies, Evaluating Medical Therapies and Articles.

Where can I get a list of the FDA approved antiretroviral HIV/AIDS drugs?

The Office of Special Health Issues maintains a listing of the FDA approved antiretroviral drugs for the treatment of HIV/AIDS.  The listing is located at www.fda.gov/oashi/aids/virals.html The Center for Drug Evaluation and Research also identifies new drug approvals on their What's New page located at www.fda.gov/cder/whatsnew.htm.

Where can I obtain information about HIV/AIDS related clinical trials?

AIDSInfo is a central resource providing current information on federally- and privately-sponsored clinical trials for AIDS patients and others infected with the human immunodeficiency virus (HIV). This free service is a Public Health Service (PHS) project provided collaboratively by the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institute of Allergy and Infectious Diseases, and the National Library of Medicine. They can also be reached by telephone at 1-800-HIV-0440 (1-800-448-0440) FAX: 1-301-519-6616, Outside US: 1-301-519-0459, TTY: 1-888-480-3739 Monday to Friday, 12:00 p.m. to 5:00 p.m. Eastern Time. Spanish-speaking health information specialists are available. Or directly at their web site at www.AIDSInfo.nih.gov.

Where can I obtain information about HIV/AIDS treatment options?

Contact www.AIDSInfo.nih.gov for federally approved treatment guidelines and information. AIDSInfo provides timely, accurate treatment information on HIV and AIDS. The service was developed through a coordinated Public Health Service. Call 1-800-HIV-0440 (1-800-448-0440) FAX: 1-301-519-6616, Outside US: 1-301-519-0459, TTY: 1-888-480-3739 Monday to Friday, 12:00 p.m. to 5:00 p.m. Eastern Time. Spanish-speaking health information specialists are available. All calls are completely confidential. Please visit the HIV/AIDS Treatment Information Service home page at: www.AIDSInfo.nih.gov

How can I get involved in the FDA HIV/AIDS drug approval process?

The Office of Special Health Issues coordinates the FDA Patient Representative Program to serve as ad hoc patient representatives at Antiviral Drugs Advisory Committee meetings. The Antiviral Drugs Advisory Committee reviews most applications for HIV/AIDS-related therapeutics that are submitted to FDA. The FDA believes that community/patient representatives being an important perspective to the committee's decision making process. The patient representative generally provide views or opinions on problems or questions pertinent to the patient's point of view.  For more information on this program please visit Community/Patient Representation on FDA Advisory Committees web page or telephone Richard Klein, Office of Special Health Issues, 301-827-4460.

What are the approved HIV Home Test Systems?

There are a number of different HIV home collection test systems and kits that have appeared on the market. FDA has put together background information about Testing Yourself for HIV-1, the virus that causes AIDS, Home Test System is Available. The address for this information is http://www.fda.gov/cber/infosheets/hiv-home2.htm
Additional information is available from the Office of Special Health Issues HIV/AIDS home page.

What is the FDA Cancer Liaison Program?

In January 1994, the Food and Drug Administration hired staff to develop the FDA Cancer Liaison Program. This program was added to an existing office, the Office of Special Health Issues. The Cancer Liaison Program staff is versed in the issues confronting patients dealing with a life-threatening illness and conversant with cancer information resources within FDA and other federal agencies, including the National Cancer Institute and the private sector. The staff works closely with cancer patients and cancer patient advocacy programs, listening to their concerns and educating them about the FDA drug approval process, cancer clinical trials and access to investigational therapies when entry into an existing clinical trial is not possible. For additional information visit the Cancer Liaison Program web site, www.fda.gov/oashi/cancer/cancer.html, or telephone them at 301.827.4460.

Where can I get information about cancer clinical trials?

Cancer Clinical Trials Listing, www.fda.gov/oashi/cancer/trials.html, an alphabetical listing of cancer organizations with extensive information about cancer treatments and clinical trials. This listing was prepared by the Cancer Liaison Program, FDA.

CancerNet, http://cancer.gov/cancerinformation/, provides links to cancer information including portions of the PDQ database, information about ongoing clinical trials, NCI fact sheets, publications, CancerNet News and CANCERLIT abstracts and citations.

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