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The Commercial Impact of REMS Relief: Nplate/Promacta Sales Spike After Risk Management Changes

This article was originally published in RPM Report

Executive Summary

Nplate and Promacta aren’t the most important products sold by Amgen and GSK. But they are among the fastest growing in 2012—thanks to a decision by FDA to relax post-market controls at the end of 2011. The change underscores the case for a different approach to REMS in oncology, and may point the way forward for broader use of the new tools in a less intrusive way.

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REMS 2.0: FDA Refining New Drug Safety Tools

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