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REMS Programs: Five Trends To Watch

This article was originally published in RPM Report

Executive Summary

As FDA’s explicit authority to require drug safety and education programs approaches its second anniversary in mid-September 2009, some very distinct trends and issues are emerging for all NDA and BLA applicants. McKesson Specialty Care Solutions is positioned directly in the risk management and distribution controls space where the new REMS post-marketing programs exist. Here are someobservations from McKesson on the developing skills and operational issues associated with designing successful REMS programs.

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