FDAnews
www.fdanews.com/articles/122036-more-rems-could-result-from-fda-8217-s-safe-use-initiative

More REMS Could Result From FDA’s Safe Use Initiative

November 9, 2009
The number of required risk evaluation and mitigation strategies (REMS) may increase under the Safe Use Initiative launched by the FDA last week. As part of the initiative, the agency will collaborate with drugmakers to identify specific drugs and drug classes associated with significant amounts of preventable harm from four sources — medication errors, unintended exposure, intentional drug misuse and drug quality defects — the agency says in a report issued Nov. 4.
Washington Drug Letter