FDA Logo links to FDA home page
U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services home page

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

horizontal rule

Updated October 2005

Office of Special Health Issues
Frequently Asked Questions

General Health Information
Patient Involvement


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

The Office of Special Health Issues has established an HIV and AIDS page. 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.

In addition, FDA has an HIV/AIDS electronic list serve that provides updates on safety and regulatory issues related to HIV/AIDS products, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings, and notices about proposed regulatory guidances. Join the HIV/AIDS e-mail list.

Where can I get a list of the FDA approved antiretroviral HIV/AIDS drugs, and other drugs used for treating complications of HIV/AIDS?

The Office of Special Health Issues maintains listings of

What are the approved HIV Home Test Systems? Can I find a list of all approved HIV tests?

There is only one approved HIV home collection test system on the market. FDA has put together background information about Testing Yourself for HIV-1. Additional information is available about HIV testing, including a list of all approved HIV tests currently on the market in the United States.

Can I find a record of HIV-related FDA advisory committee meetings?

The Office of Special Health Issues maintains a listing of HIV-specific advisory committee meetings since 1996 for drugs, biologics, devices, and policy issues related to HIV/AIDS.

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. AIDSinfo also offers Live Help to provide one-on-one assistance via the internet to help you navigate the AIDSinfo web site, find answers to your questions about federally approved information on HIV/AIDS treatment and prevention research, HIV/AIDS clinical trials, and treatment and prevention guidelines. This service is available Monday - Friday, 12:00 p.m. - 4:00 p.m. Eastern Time. You may also call AIDSinfo 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. All calls are confidential.

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.


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, or telephone them at 301.827.4460.

Where can I get information about clinical trials for cancer or other conditions?

CancerNet provides links to cancer information including portions of the PDQ database, information about ongoing clinical trials, National Cancer Institute (NCI) fact sheets, publications, CancerNet News and CANCERLITE abstracts and citations.

ClinicalTrials.gov is an interactive data base that can help you locate both government and privately sponsored clinical trials clinical trials for other serious illnesses. It is maintained by the National Library of Medicine, which is part of the National Institutes of Health (NIH).

Other information for consumers and patients about clinical trials can be found on the FDA Clinical Trials page.

General Health Information

Where can I find information on other health topics?

A good source of information on various disease conditions, drugs, surgical procedures, and other general health topics can be found at MedlinePlus, a web site of the National Library of Medicine.

Information about disease prevention, wellness, medical check-ups, the latest health news, and health advocacy organizations can be found at Healthfinder, a federal government sponsored web site for health related information.

Patient Involvement at FDA

How can I get involved in decision-making at FDA?

FDA's Patient Representative Program provides FDA and FDA advisory committees with the unique perspective of patients and their family members or patient advocates directly affected by a serious or life-threatening disease.

FDA's Cancer Drug Development Patient Consultant Program incorporates the perspective of cancer patient advocates into the drug development process by allowing them an opportunity to participate in the FDA drug review regulatory process.

horizontal rule