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Medical News FDA Fast Tracks Biosyn Gel ProductNovember 19, 2003 Biosyn Inc. of Huntingdon Valley, Pa., announced Monday that the Food and Drug Administration had granted "fast track" designation to its C31G vaginal gel designed to reduce HIV transmission. "We have worked closely with the FDA on the clinical path for this candidate since it is an important product for the prevention of sexual transmission of HIV," said Anne-Marie Corner, president and CEO. Fast track programs facilitate the development and expedite the review of new drug candidates intended to prevent or treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Biosyn's gel is entering phase III clinical trials for prevention of HIV transmission, prevention of chlamydia and contraception. Philadelphia Business Journal 11.17.03  This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update. |
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