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REMS 2.0: FDA Refining New Drug Safety Tools

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA’s new post-marketing risk management authorities are receiving much more public attention in the context of the Avandia decision – but use of Risk Evaluation and Mitigation Strategies is actually declining. As FDAAA turns three, it is clear that REMS are going through some growing pains. The new tools will be refined, but they are definitely here to stay.

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