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In Brief: Vaginal Microbicides

Executive Summary

Vaginal Microbicides: FDA's Anti-Infective Drugs Advisory Committee will meet jointly with the Reproductive Health Drugs, Antiviral Drugs and the Nonprescription Drugs Advisory Committees Nov. 20-22 to discuss issues of microbicidal topical vaginal agents. The Anti-Infective Drugs Advisory Committee will meet the morning of Nov. 20 in a closed session; the four committees will meet in the afternoon to discuss issues relevant to the use of microbicidal topical vaginal agents as prophylaxis against STDs such as chlamydia and gonorrhea. FDA will ask committees for advice on developing policy on quality and type of data available to support use of the agents, labeling issues and the appropriate target audience. The committees will meet Nov. 21 to discuss a guidance on the development of vaginal products for protection against HIV infection, and on Nov. 22 to discuss the proposal of clinical efficacy studies of marketed vaginal spermicides. The committees will meet all three days at the Gaithersburg, Md. Holiday Inn...
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