U.S. Food and Drug Administration


AIDS Red Ribbon HIV and AIDS AIDS Red Ribbon

HIV/AIDS Therapies

Approved therapies, treatment guidelines.

Clinical Trials and Drug Development

"Fast track" drug programs, pediatric patients, studying therapeutics in women.

Resources for Investigational New Drug (IND) Applications

IND Application Process: What you need to know about requirements and guidances necessary for drug development and marketing approval.

Antiviral Products Pre-IND Program

Getting started with the Pre-IND process in development of HIV/AIDS therapies.

FDA/State AIDS Health Fraud Task Force

Task forces combating scams relating to HIV/AIDS, cancer, dietary supplements, and other treatments.

Barrier Products

Such as condoms, gloves and other medical devices.

HIV Testing Information

Home test kits (legitimate and fraudulent) and clinical setting tests.

Blood Donor Deferral and High-Risk Behavior

Men who have had sex with another man (MSM): Donor deferral based on sexual risk behaviors


Significant events 1981 - present

Patient Representative Program

A program developed to bring the patient voice to the table at FDA advisory committee meetings, and assure patient community input into regulatory issues and drug approval.

What's New at FDA in HIV/AIDS

Late breaking information, as well as an archival record of updates on safety and regulatory issues related to HIV/AIDS, dating from 2002 to present. Information includes

  • product approvals
  • significant labeling changes
  • safety warnings
  • notices of upcoming public meetings
  • notices about proposed regulatory guidances

Get news updates by e-mail

You can get updates on drug safety and regulatory issues related to HIV/AIDS by joining the FDA HIV/AIDS List Serve.

FDA's Role in HIV

Other Government Resources

An information gateway to guide users to federal domestic HIV/AIDS information and resources, providing access to information on federal HIV/AIDS prevention, testing, treatment, and research programs, policies, and resources.

Information about the current treatment regimens for HIV infection and AIDS-related illnesses, including the prevention of HIV transmission from occupational exposure and mother-to-child transmission during pregnancy.

AIDSinfo is also a resource for current information on clinical trials for AIDS patients and others infected with HIV.

Divisions of HIV/AIDS Prevention (Centers for Disease Control and Prevention) provides information about populations affected by HIV/AIDS, and prevention.

National Prevention Information Network (CDC)
the nation's largest collection of information and resources on HIV/AIDS, STD and TB prevention.

Division of AIDS (National Institutes of Health) provides information about HIV/AIDS prevention, therapeutics, and vaccine research.

HIV/AIDS Bureau (Health Resources and Services Administration) provides information about the Ryan White Care Act (which fills gaps in health care for people with HIV disease for those with low-incomes and little or no insurance), grant opportunities, education, and training.

News Releases

Press Releases and Talk Papers related to AIDS and HIV.

HIV/AIDS Meetings

On December 11, 2008, The FDA Obstetrics and Gynecology Devices Panel met to discuss, make recommendations, and vote on a premarket approval application for the FC2 Female Condom, sponsored by the Female Health Company. This device is indicated to help prevent HIV/AIDS and unintended pregnancy. The meeting was held in Gaithersburg, MD.

FDA Advisory Committees

HIV-specific advisory committee meetings for drugs and biologics, and policy issues related to HIV/AIDS.


Articles and brochures by FDA staff on AIDS and HIV.


Contact the HIV/AIDS Program

Contact the Office of Special Health Issues


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