Information by Drug Class Questions and Answers: FDA Requires a Risk Evaluation and Mitigation Strategy (REMS) for Long-Acting and Extended-Release Opioids FDA announcement.pdf
Q & A about REMS
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm251752.htm?sms_ss=email&at_xt=4daebacc1507e123%2C0