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Truvada PrEP REMS Needs More Work, FDA Panel Says

 
• By Sue Sutter

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.

An FDA advisory committee endorsed the use of Gilead Sciences Inc. HIV drug Truvada (emtricitabine/tenofovir) for pre-exposure prophylaxis (PrEP) but called for a stricter Risk Evaluation and Mitigation Strategy than that proposed by the sponsor, including possibly linking prescribing to evidence of a negative HIV test.

In a marathon, 12½-hour meeting May 10, the Antiviral Drugs Advisory Committee voted to support the use of Truvada as...

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AMR-Targeting Drug Secures EMA PRIME Designation

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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