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Truvada For PrEP Approval Reflects Limits Of REMS Assessments

Executive Summary

In approving the antiretroviral fixed-dose combination for pre-exposure prophylaxis, FDA is requiring Gilead to gather information about the development of viral resistance and compliance with HIV testing requirements “to the extent possible,” suggesting a willingness to be flexible on REMS assessments when the data may be hard to come by. Further clarity is expected from mandatory post-marketing studies.


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