Richard Klein

Office of Special Health Issues, Food and Drug Administration 

FDA Advisory Committees to Examine a Number of HIV Issues in May


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 Approves New Rapid HIV Test Delivering Results in 60 Seconds

Richard Klein

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…