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

 
• By Michael McCaughan

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.

FDA’s use of the Risk Evaluation & Mitigation Strategy authority declined for the the third consecutive year. That is a remarkable trend, considering that the REMS have existed for just four years.

FDA was granted the formal authority to impose post-marketing risk management plans and clinical trials under the FDA Amendments Act of 2007, with the relevant portions kicking in in 2008....

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