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An Emerging REMS Dilemma: Qnexa, Truvada – and Korlym

This article was originally published in RPM Report

Executive Summary

Two high-profile applications pose a thorny dilemma for FDA: how to impose a REMS for a new indication without restricting access for already approved uses where restrictions are not appropriate. That same issue didn’t seem to slow the agency down on a recent approval decision involving a very controversial ingredient.

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