Entering the World of REMS: Entereg Sets New Standard

Entereg is the most important new drug approved by FDA so far in 2008. Not because of its commercial prospects, which are far more limited than development partners GSK and Adolor once hoped for, but because it is a precedent-setting use of the agency's new drug safety authorities-and a case study in how those new tools can save a drug that might otherwise never have been marketed at all.