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Gilead’s REMS Resubmission Delays FDA Action On Truvada For PrEP

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA extends the user fee deadline for the supplemental indication of HIV pre-exposure prophylaxis to Sept. 14. Although Gilead is not saying what changes it made to the Risk Evaluation and Mitigation Strategy, FDA advisory committee members had recommended making prescriber education mandatory and linking prescribing to documentation of a negative HIV test.

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