FDA Feed

December 03, 2010


FDA Approves New Rapid HIV Test Delivering Results in 60 Seconds

By Richard Klein, Office of Special Health Issues, Food and Drug Administration

Richard Klein, FDA

Richard Klein, FDA.

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 rapid HIV tests, which typically deliver results in about 10 - 20 minutes.

The new test contributes to the tools available to us as we work toward the National HIV/AIDS Strategy's goal of increasing the number of people living with HIV who know their serostatus, a critical step in our efforts to curb the spread of HIV/AIDS. Rapid HIV tests allow people to learn their HIV status in a single visit to a testing site, instead of returning days later for results, dramatically increasing the number of people who ultimately learn their serostatus after taking an HIV test.

Rapid testing also helps increase access to HIV testing because testing can be performed outside of the traditional laboratory setting. Individuals who undergo testing can be counseled immediately concerning their HIV status and, if they are positive, given the opportunity to enter medical care.

Read more about FDA's approval of the INSTI™ HIV-1 Antibody Test.

February 23, 2010


FDA Advises Patients and Care Providers on Drug Combination Safety Considerations

By Erica Jefferson, the 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 from clinical trials, indicate that the two drugs taken together may affect the normal electrical activity of the heart.

Continue reading "FDA Advises Patients and Care Providers on Drug Combination Safety Considerations" ยป


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