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Microbicide Field Wrestles With the Implications of Success -- an Update

Winter 2011

On October 25, 2010, the nonprofit microbicide research organization CONRAD announced that the U.S. Food and Drug Administration (FDA) would consider the Vaginal and Oral Interventions to Control the Epidemic (VOICE) trial as a confirmatory trial to the CAPRISA 004 results (see TAGline vol 17, no. 3). Further, the FDA has agreed to accept fasttrack designation for the 1% tenofovir gel microbicide, meaning that the clinical trial sponsor may submit completed sections of the new drug application for review by the FDA rather than waiting until the entire application is complete. This can speed the way for approval if the VOICE trial results confirm those obtained in CAPRISA 004. The FDA did identify some specific additional information that will be required, including safety data in adolescents,

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