Daily Archives: February 10, 2009

FDA to Get More Specific on REMS and Painkillers

Posted on February 10, 2009 by Mark Senak

Yesterday, the FDA announced that it has sent letters to the manufacturers of both generic and brand name opioid based products that they may be required to have a Risk Evaluation Mitigation Strategy (REMS), which the agency now has the … Continue reading →

Posted in FDA Policy, Risk Management | Comments Off on FDA to Get More Specific on REMS and Painkillers