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FDAAA Impact Analysis (Year 4): The REMS Retreat Continues, But For How Long?

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

As the fifth year of the REMS era begins, FDA is imposing mandatory programs less frequently than it did even in the first year after the law creating formal risk management plans took effect. But there are some new trends to watch, including the evolution of REMS classes and the emergence of products with REMS-in-waiting.

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