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Truvada PrEP REMS Needs More Work, FDA Panel Says

This article was originally published in The Pink Sheet Daily

Executive Summary

In a marathon meeting, the Antiviral Drugs Advisory Committee endorses use of Gilead’s emtricitabine/tenofovir fixed-dose combination for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV infection, but some committee members say Gilead’s REMS needs more “teeth,” including a linkage between a documented negative HIV test and access to the drug.


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