Cross-posted from the FDA Blog World AIDS Day has been observed in the United States on December 1 since 1995. When I look back at early World AIDS Day observances, I remember them as a way of raising awareness of the men, women and children who had no advocates, no representation, no medicines, and practically…
World AIDS Day
November 30, 2012 • 0 comments • By Steve Morin, R.N., B.S.N., Health Programs Coordinator, FDA Office of Special Health Issues
FDA approves first drug for reducing the risk of sexually acquired HIV infection
Today (July 16, 2012), the U.S. Food and Drug Administration approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, is to be used for…
FDA Advisory Committees to Examine a Number of HIV Issues in May
April 18, 2012 • 1 comment • By Richard Klein, Office of Special Health Issues, Food and Drug Administration
The U.S. Food and Drug Administration (FDA) has three important advisory committee meetings scheduled in May that may impact HIV prevention, detection, and treatment. On May 10, 2012, FDA’s Antiviral Advisory Committee will discuss expanding the indication of Truvada (emtricitabine/tenofovir disoproxil fumarate) tablet, made by Gilead Sciences, Inc., to include use for Pre-Exposure Prophylaxis (PrEP),…
FDA and FTC Act to Remove Fraudulent HIV and STD Products from the Market
June 9, 2011 • 0 comments • By Miguel Gomez, Director, AIDS.gov, and Senior Communications Advisor, Office of HIV/AIDS Policy, U.S. Department of Health and Human Services
Last month the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) announced a joint effort to remove products from the market that make unproven claims to treat, cure, and prevent sexually transmitted diseases (STDs), including HIV/AIDS. Among the products targeted in the action are Medavir, Herpaflor, Viruxo, C-Cure, and Never An…
FDA Approves New Rapid HIV Test Delivering Results in 60 Seconds
December 3, 2010 • 2 comments • By Richard Klein, Office of Special Health Issues, Food and Drug Administration
Earlier this week the Food and Drug Administration (FDA) announced the approval of the INSTI™ HIV-1 Antibody Test, a new, single use rapid test for the detection of HIV antibodies developed by bioLytical Laboratories of Canada. The newly approved test provides results in as little as 60 seconds, in contrast to the six previously approved…
FDA Advises Patients and Care Providers on Drug Combination Safety Considerations
February 23, 2010 • 1 comment • By Erica Jefferson, Office of Public Affairs, U.S. Food and Drug Administration
The U.S. Food and Drug Administration (FDA) is committed to keeping the public updated on advances and shifts in treatment options and methods. The FDA is reviewing data that suggest use of the HIV drug Invirase (saquinavir) in combination with Norvir (ritonavir) may have a potentially serious effect on a patient’s heart. The data, drawn…