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Kaiser Pushes Back on REMS: Acorda Listens; Will FDA?

This article was originally published in RPM Report

Executive Summary

Kaiser recognizes that some sponsors are trying to use REMS to make an end-run around gatekeepers, and it is fighting back. The non-profit integrated care system wants FDA to help, filing a citizen petition that could profoundly affect commercialization of new products in the US. The recently approved MS drug Ampyra offers a case-in-point.

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